Pharmaceutical Manufacturing at McGuff Pharmaceuticals

I find that the harder I work, the more luck
I seem to have. Pharmaceutical Manufacturing Management

– Thomas Jefferson

Career Opportunities

At McGuff, we attract and recruit the finest people in the world. Whenever possible, we build our organization from within, promoting and rewarding people with regard only to performance. When internal candidates are unavailable or we search for candidates with different qualifications we search for the most qualified candidates from outside the organization.

McGuff values its employees as a key resource. An atmosphere of good employee communication, involvement and responsibility is of central importance. Employee’s personal development and optimum use of talents is encouraged.

McGuff in the News

Current Job Openings:

Division Position Location
McGuff Pharmaceuticals, Inc. Senior Product Development Engineer Santa Ana, CA
McGuff Pharmaceuticals, Inc. Senior Pharmaceutical Marketing Manager Santa Ana, CA
McGuff Pharmaceuticals, Inc. Manufacturing Technician Santa Ana, CA
McGuff Pharmaceuticals, Inc. Maintenance Technician / Mechanic Santa Ana, CA
McGuff Pharmaceuticals, Inc. Engineering Technician Santa Ana, CA
McGuff Pharmaceuticals, Inc. Quality Engineering and Validation Specialist Santa Ana, CA
McGuff Pharmaceuticals, Inc. Regulatory Affairs Analyst Santa Ana, CA

McGuff Pharmaceuticals, Inc. - Senior Pharmaceutical Marketing Manager

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed pharmaceutical manufacturer, FDA registered and an ISO 9001:2000 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is sure to provide opportunities for personal growth and development. Join us as we continue our quest to improve our products, quality systems, and facilities to exceed customer expectations.

We are searching for an entrepreneurial, highly motivated Senior Pharmaceutical Marketing Manager for National and International Marketing to be located in our Santa Ana California Office. The incumbent will have direct responsibility for developing and implementing our commercial strategy for the launch and brand life cycle management of our injectable drug products.

Job Description

This position reports to Vice President of Operations, McGuff Pharmaceuticals.

Responsibilities will include, but not be limited to:

  • Promote, manage and ensure market penetration and expanding sales for a key orphan drug product.
  • Promote and ensure continued sales and expansion for additional assigned products into a wide array of markets and various products are developed and approved by regulators.
  • Monitor and keep abreast of industry trends, customer needs, and regulatory/payer dynamics to enhance or distinguish our new injectable drug in national and international commerce.
  • Be our subject matter expert in pharmaceutical pricing strategies and reimbursement mechanisms for national and international markets.
  • Establish interactions with government purchasers, wholesalers, hospitals and physicians to achieve market penetration.
  • Establish international contacts and relationships that will assist in our efforts to obtain numerous international approvals, build sales and implement logistics within the selected countries.
  • Collaboration with the cross functional commercial team on annual strategic planning
  • To become the subject matter expert to provide information about expanded options and opportunities for additional uses of assigned products while simultaneously ensuring all regulatory requirements for product promotion are consistently met.

Required Skills:

  • Bachelor's Degree or Equivalent, MBA preferred
  • Minimum 5 years of healthcare, pharmaceutical or biotechnology experience, with at least 3 years in a strategic US / International marketing role
  • Experience in digital marketing or social media preferred
  • Strong communication and interpersonal skills along with the ability to work well with others
  • Ability to work with multiple internal cross-functional teams and successfully manage multiple projects simultaneously
  • Demonstrated consistent track record of success and delivering strong results
  • Strong scientific/medical aptitude and experience
  • Demonstrated success in project, vendor, and budget management
  • Willingness/ability to travel up to 25%
  • Strong alignment to our corporate values of patient at center, collaboration, relentless pursuit of excellence and trust in all we do

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: employment.mpi@mcguff.com

McGuff Pharmaceuticals, Inc. - Shipping / Receiving Warehouseman

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed pharmaceutical manufacturer, FDA registered and an ISO 9001:2000 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is sure to provide opportunities for personal growth and development. Join us as we continue our quest to improve our products, quality systems, and facilities to exceed customer expectations.

McGuff Pharmaceuticals, Inc. has an opening for a personable individual for shipping/receiving and inventory control position (Shipping/Receiving Warehouseman). Must be a team player that will become involved in various aspects of logistics. Position requires a detail oriented individual with good oral & written skills, have a good driving record. Friendly, non-smoking warehouse with a positive environment. Santa Ana/Costa Mesa area.

Job Description

  • Receive and quarantine materials as required per Standard Operating Procedures (SOP).
  • Ship goods as required per SOP
  • Control and maintain all warehouse stock
  • Control and maintain raw materials, in-process and finished goods quarantine areas as required.
  • Control and maintain label stock as required per SOP.
  • Work with the company's electronic accounting systems to stock, track, and control materials.
  • Back up to perform Quality Control (QC) testing on received materials and assist in sample collection preparation for QC laboratories (as assigned).
  • Work with other departments to ensure ongoing cGMP and ISO requirements are met.
  • Insuring that the facility is clean and orderly
  • Stock supplies.
  • Perform other varied duties as assigned.

Physical Requirements:

The employee must bend, squat, climb, reach above shoulder level, sit, stand, walk, and handle various parts/components and varied objects (manual dexterity). On the job employees must be capable of repetitively lifting/carrying up to 75 pounds and manipulating upwards of 200 lbs.

Qualifications include:

  • Use of personal automobile to pick up and/or deliver materials.
  • Possession of valid California State Driver's License
  • Automobile Insurance
  • v Forklift operator training (will train and certify)
  • Proficient in speaking, reading, and writing English.
  • Knowledge of FDA cGMP requirements preferred (but will train)
  • Knowledge of ISO 9000 requirements preferred (but will train)
  • Detail oriented
  • Ability to follow detailed SOPs for process and material sample collection and testing.

Expectations:

  • Appropriate professional demeanor.
  • Work with all McGuff employees to foster and promote quality system controls and procedures.
  • Knowledge, understanding and compliance with appropriate work SOPs.
  • Knowledge, understanding and compliance of the dress code.
  • Ability to work with others.
  • Adequate communication skills.

Interested candidates please indicate “Warehouse Rep.” on your cover letter or resume and include salary history. Resumes without salary history will not be considered. You may send your resume and salary history via email to the contact indicated below. No telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: damon@mcguff.com

McGuff Pharmaceuticals, Inc. - Senior Product Development Engineer

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for a Senior Product Development Engineer within our Manufacturing Division located in Santa Ana, CA. This position reports to the Manager of Product Development.

The Senior Product Development Engineer will oversee and be responsible for assigned Product Development projects for McGuff Pharmaceuticals. Responsibilities extend to all activities related to product development of pharmaceutical dosage forms. The Senior Product Development Engineer will work closely with company personnel to ensure that all applicable project objectives, policies, procedures, state and federal laws, and ISO requirements are met.

Duties shall include:

Responsible for coordinating and implementing activities related to future and ongoing product development including:

  • Implementing departmental policies, programs and procedures for product development.
  • Plan, organize and lead product development projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of product development activities and tasks.
  • Organizing resources to achieve the goals in an optimum fashion.
  • Establishing effective communications and guiding project members to accomplish stated project objectives.
  • Coordinating and managing assigned product development and engineering activities, as assigned by the department Manager.
  • Meeting strategic objectives for company growth.
  • Process and Product Development for targeted products to ensure finished products meet the required safety, identity, strength, quality and purity they purport to possess. This includes developing and defining product specifications, procedures, and controls.
  • Provides technical guidance to department staff as required in areas related to product development such as characterization, pre-formulation, formulation and process development, scale-up, preparing clinical supplies, technology transfer, manufacturing scale-up, and formulation and process improvement.
  • Troubleshooting, failure analysis and corrective action of design and processing errors
  • Working with Manufacturing, Quality Systems and other personnel to ensure anticipated product development activities and outputs are planned and effectively executed.
  • Coordinating product and process engineering, qualification, and validation studies as needed.
  • Assurance that product development activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND requirements)
  • As assigned by the Product Development Manager, working with customers and clients to define and implement contract manufacturing opportunities to meet customer requirements and exceed expectations.
  • As assigned by the Product Development Manager, working with customers and other employees to develop, implement and control clinical trials.
  • Other duties as assigned.

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds.

Qualifications Include

  • Education: Bachelor of Science in Engineering, Chemistry or related field degree. Advanced technical degree is a plus: Masters of Science, or PhD Degree.
  • Minimum of 5 years relevant industry experience.
  • Experience with regulated industry Product Development and Regulatory requirements.
  • Familiar with Chemistry, Engineering and Manufacturing operations.
  • Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANDA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
  • Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.
  • Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.
  • Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.
  • Ability to develop formulations, processes, and pharmaceutical products.
  • Working understanding of statistical techniques including experimental design.
  • Knowledge of ISO 9000 requirements.
  • Knowledge of FDA requirements (cGMP and marketing applications)
  • Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
  • Type a minimum of 45 words per minute.

Expectations:

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans.

Interested candidates please indicate “Senior Engineer” on your cover letter or resume. Please send resumes via e-mail, Attention: Product Development Manager. No telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time

Contact Information:

employment.mpi@mcguff.com
McGuff Pharmaceuticals, Inc.

McGuff Pharmaceuticals, Inc. - Manufacturing Technician

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has an opening for a Manufacturing Technician within our production facility located in Santa Ana, CA. This position reports to the Production Supervisor.

The candidate must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.

Duties include:

  • Operation of pharmaceutical manufacturing equipment including automated aseptic fill lines, washers, ovens, and autoclaves
  • Responsible for set-up, adjustments, sanitization, minor maintenance, and operation of all machinery in the sterile filling area
  • Experience in using aseptic technique to conduct aseptic filtration and filling of finished product
  • Knowledge of current Good Manufacturing Practices (cGMP) guidelines
  • Capable of following standard operating procedures (SOP’s) in performing tasks
  • Responsible for supply of components into processing areas
  • Compounding of bulk solutions
  • Accurate completion of production documentation and all appropriate log books.
  • Other duties as assigned (e.g. may include material stocking and assisting Engineering and the on-sight laboratories in various projects as assigned).

Entry level candidates are welcome. Preferred candidates will be familiar with pharmaceutical production, and have one to three years experience in related pharmaceutical/pharmacy activities. Knowledge of cGMP / ISO 9001 preferred. Enjoy excellent working conditions. Hours: day shift (flexible), M-F. Santa Ana/Costa Mesa area. All applicants must send salary history with current resume. Resumes without salary history will not be considered. Please send resumes and salary history via e-mail to employment.MPI@mcguff.com or FAX to 714-384-4634, Attn: Engineering and Production Supervisor.

McGuff Pharmaceuticals, Inc. - Manufacturing / Production Technician

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has an opening for a Manufacturing/Production Technician within our production facility located in Santa Ana, CA. This position reports to the Production Supervisor.

The candidate must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.

Duties include:

  • Primary job function is to perform tasks in support of routine production operations.
  • Responsible for operating, cleaning, set-up, adjustments, sanitization and minor maintenance of all machinery in the sterile filling area (e.g. automated aseptic fill lines, washers, ovens, autoclave, cooling systems and WFI/Pure Steam generator)
  • Experience in using aseptic technique to conduct aseptic filtration and filling of finished drug product
  • Facility cleaning, sanitation, and pest control including critical cleaning and disinfection of Clean Room areas
  • Responsible for supply of components into processing areas
  • Compounding of bulk solutions
  • Read, comprehend, and execute procedures as written
  • Accurate completion of production documentation and all appropriate log books
  • Knowledge of current Good Manufacturing Practices (cGMP) guidelines
  • Assure the customers needs are satisfied and help out wherever is needed
  • Other duties as assigned (e.g. may include material stocking and assisting Engineering and the on-sight laboratories in various projects as assigned)

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds and manipulating upwards of 200 lb.

Qualifications include:

  • The Manufacturing/Production technician must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.
  • Education: high school diploma or equivalent
  • Experience: Previous experience (direct or related) as a manufacturing/production technician preferred.
  • Knowledge of FDA cGMP requirements (will train)
  • Knowledge of ISO 9000 requirements (will train)
  • Competent to perform the duties outlined in the job description and physical requirements

Expectations:

  • Appropriate professional demeanor
  • Work with all McGuff employees to foster and promote quality system controls and procedures
  • Knowledge, understanding and compliance with appropriate work SOPs
  • Knowledge, understanding and compliance of the dress code
  • Ability to work with others
  • Good communication skills

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans.

Candidates must be familiar with pharmaceutical manufacturing, and have one to three years experience in related pharmaceutical/pharmacy activities. Knowledge of cGMP / ISO 9001 preferred. Enjoy excellent working conditions. Hours: day shift (flexible), M-F. Santa Ana/Costa Mesa area. All applicants must send salary history with current resume. Resumes without salary history will not be considered. Please send resumes and salary history via e-mail to employment.MPI@mcguff.com Attention: Production Supervisor. No telephone calls please.

McGuff Pharmaceuticals, Inc. - Shipping/Receiving Warehouse Person

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for a Shipping/Receiving Warehouse Person within our Manufacturing Division located in Santa Ana, CA. This position reports to the Logistics and Facilities Supervisor.

The candidate must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.

Duties shall include:

  • Receive and quarantine materials as required per standard operating procedures (SOP)
  • Ship goods as required per SOP
  • Control and maintain all warehouse stock
  • Control and maintain raw materials, in-process and finished goods quarantine areas as required
  • Control and maintain label stock as required per SOP
  • Work with the company's electronic accounting systems to stock, track, and controls materials
  • Back-up to perform QC testing on received materials and assist in sample collection preparation for QC laboratories (as assigned)
  • Work with other departments to ensure ongoing cGMP and ISO requirements are met
  • Stock supplies
  • Operate forklift
  • Perform other varied duties as assigned.

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds and manipulating upwards of 200 lb.

Qualifications include:

  • Use of personal automobile to pick up and/or deliver materials
  • Possession of valid California State Driver's License
  • Automobile Insurance
  • Forklift operator training (will train and certify)
  • Proficient in speaking, reading, and writing English
  • Knowledge of FDA cGMP requirements preferred (but will train)
  • Knowledge of ISO 9000 requirements preferred (but will train)
  • Detail oriented
  • Ability to follow detailed SOPs for process and material sample collection and testing

Expectations:

  • Appropriate professional demeanor.
  • Work with all McGuff employees to foster and promote quality system controls and procedures
  • Knowledge, understanding and compliance with appropriate work SOPs
  • Knowledge, understanding and compliance of the dress code
  • Ability to work with others
  • Good communication skills

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans. Interested candidates please indicate “Shipping/Receiving Warehouse Person” on your cover letter or resume and include salary history. Resumes without salary history will not be considered. You may send your resume via email to employment.mpi@mcguff.com Attention: Facilities and Logistics Supervisor. No telephone calls please.

McGuff Pharmaceuticals, Inc. - Manager of Quality Systems

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for Manager of Quality Systems within our Manufacturing Division located in Santa Ana, CA.

Description/Primary Responsibilities:

To provide leadership and develop, manage, coach and maintain all Quality Systems and Quality Functions for McGuff Pharmaceuticals and support the Quality Functions of sister divisions, McGuff Compounding Pharmacy Services, Inc. and McGuff Company. To enable and ensure proactive, metric driven, management of Quality, commensurate with risks, for ongoing process and product safety and efficacy. Utilize Systems design, development and management skills along with analytical and problem solving skills to develop and optimize Quality Systems, procedures, personnel and overall company performance. The Quality Systems Manager will oversee and be responsible for insuring and refining all facets of the Quality System are effective, efficient, meet company objectives, maintain a state of regulatory compliance and ensure product integrity and patient benefit and safety.

The Quality Systems Manager will interact and develop hands-on knowledge concerning the daily activities of the Quality Systems group and work to ensure quality pharmaceuticals are prepared and released for patient benefit. Duties and responsibilities generally include: (1) Implementation, management and continuous improvement of the Quality Systems of McGuff Pharmaceuticals, (2) Quality Assurance and Quality Control unit responsibilities according to cGMP requirements (3) Supervise QS personnel, (4) Authority for release and rejection of all components, drug product containers, closures, in-process materials, packaging materials, labeling, and finished drug products. (5) Authority to review control records to assure that no errors have occurred, (6) authority to ensure and verify that manufacturing errors are fully investigated and documents as appropriate. He/she will work closely with other department Managers to ensure that all applicable policies and procedures, state and federal laws and regulations, ISO and cGMP requirements are met.

The following list of duties and tasks is illustrative ONLY and is not a comprehensive listing of all functions and tasks performed by positions in this class. It does not necessarily list all possible duties that may be assigned.

  • Identify and implement strategic quality objectives.
  • Work with senior management to ensure effective Quality Systems are in place for all aspects of the company’s products and services.
  • Responsible for all Quality Systems sections including, Quality Assurance, Quality Control and Quality Laboratories (Microbiology and Chemistry).
  • Identifying and leading Quality Improvement plans and objectives.
  • Daily supervision of Quality System personnel assignments and duties.
  • All Quality System functions including but not limited to
    • Incoming material QC.
    • In-process Quality controls and inspections.
    • Finished product release, approval or rejection (or assignment to designated QC unit personnel).
    • Non-conformance management systems.
    • Customer feedback systems.
    • CPAT System administration and coordination.
  • Managing all work schedules and personnel within the Quality Systems group.
  • Recognize the need for investigations due to deviations from written procedures, review investigations into non-conformance incidents/deviations, and recommend disposition of the affected product/component.
  • Prepare and ensure timely completion of deviation/investigation reports.
  • Prepare trend reports related to in-process monitoring, deviation reports, investigation reports and CAPAs.  Follow-up with functional department for timely completion of corrective and preventive actions recommended.
  • Perform annual and random audits of production, warehouse, maintenance, and analytical laboratory, etc.
  • Recommend continuous improvement plans based on observation of process, vendors, data, etc. to management.
  • Maintain a thorough knowledge of appropriate standard operating procedures.
  • Recommend/initiate SOP updates and improvements as appropriate.
  • Monitor and audit manufacturing for cGMP compliance and serve as a key resource to production regarding quality and compliance issues.
  • Conduct product complaint and adverse event investigations and prepare responses as needed.
  • Review/approve change control documentation.
  • Assist in hosting outside audits, i.e. FDA audits.
  • Perform personnel evaluations as needed.
  • Participate in customer service/support activities as assigned.
  • Other varied duties as assigned by his/her immediate Manager.

Physical Requirements:

The position requires minimal bending, squatting, climbing, and reaching above shoulder level.  In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement).  The position will require occasionally lifting/carrying up to 50 pounds.

Qualifications include:

  • Education: Bachelor of Science degree in related field or comparable additional experience.
  • Minimum of fifteen (15) years relevant industry experience.
  • Minimum of three (3) years of experience at a Manager level is preferred
  • Experience with quality systems related to the Pharmaceutical Industry.
  • Experience with interacting with various regulatory bodies and regulators (e.g. FDA, CDER, ISO and State Boards of Pharmacy).
  • Knowledge of FDA cGMP requirements.
  • Knowledge of ISO 9000 requirements.
  • Knowledge of QA laboratory operations, methods and controls.
  • Computer literate and familiar with computerized records, control systems and ERP systems

Expectations:

  • Appropriate professional demeanor.
  • Knowledge, understanding and compliance of the dress code and corporate policies.
  • Ability to work with others.
  • Excellent verbal and written communication skills are mandatory.  Attention to detail in communication is essential.  Ability to carefully proofread reports and obtain corrections of any flaws is required.
  • Work with all McGuff employees to foster and promote quality throughout both organizations.
  • Excellent customer skills

At McGuff Pharmaceuticals, Inc. we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer.  McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401k retirement plans.

Interested candidates please indicate "Quality Systems Manager" on your cover letter or resume and include salary history.   Resumes without salary history will not be considered. You may either send your resume via email.  No fax or telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time

McGuff Pharmaceuticals, Inc. - Facilities and Maintenance Specialist (FMS)

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for Supervisor of Quality Engineering and Validation within our Manufacturing Division located in Santa Ana, CA.

Description/Primary Responsibilities:

The Facilities and Maintenance Specialist (FMS) will be responsible for maintenance and repair of equipment and facilities for McGuff Pharmaceuticals working with minimal supervision. The FMS will plan, coordinate and execute facilities and equipment operational readiness including, but not limited to, maintenance of facilities, buildings and equipment, managing the preventive maintenance system, equipment specifications development, managing the calibration system, and coordinating and organizing the spare parts and tools inventory. Responsibilities also include maintenance and troubleshooting of cGMP production equipment. The FMS will also support and execute assigned qualifications and validations. Responsibilities will also include troubleshooting and solving production process problems with processes or equipment already in operation. The FMS shall ensure McGuff operations are compliant with cGMP requirements. The FMS will also be a technical Subject Matter Expert (SME) with input to Engineering, Product Development and Quality Systems departments for mechanic, maintenance and engineering related topics and issues.

  • Hands on leadership in preventive maintenance and repairs for facility, cGMP manufacturing, equipment and infrastructure.
  • Manage and maintain functional capabilities for all equipment and facilities.
  • Coordinate, implement, and participate in preventative and reactive maintenance according to SOPs/work instructions as necessary.
  • Develop and implement facility safety initiatives and good house-keeping for the safe performance of assigned duties.
  • Make appropriate facility and equipment adjustments or modifications within company and GMP guidelines and notify Quality Systems of any abnormal parameters.
  • Lead and organize specialized maintenance and equipment projects.
  • Managing the appropriate components and repair equipment stock which will result in limited production down time and unnecessary crisis management.
  • Monitor and maintain HVAC systems verifying they are running properly and efficiently.
  • Complete and maintain necessary documentation including applicable cGMP documents.
  • Understand qualification of process equipment and facilities.
  • Be the Subject Matter Expert (SME) for equipment and facilities and work with Quality Systems staff to troubleshoot, correct and prevent non-conforming products, process, materials, as necessary.
  • Other varied duties as assigned.

Minimum Requirements:

  • Education: High school diploma or equivalent.
    • Preference will be given to candidates with extended education.
  • Minimum of 5 years relevant hands on industry experience in a manufacturing or packaging environment. Prefer candidates with experience in pharmaceutical manufacturing.
  • Strong familiarity with various Pharmaceutical manufacturing equipment such as Automated Fill Lines, Autoclaves, Boilers (less than 100psi), Ovens, Washers, Cleanrooms, HVAC, WFI Stills and various control systems.
  • Strong background in machine maintenance and troubleshooting skills. Knowledge and experience working with machine control systems including PLCs (AB, Siemens, etc.), I/O devices, servo controls, and varied pharmaceutical manufacturing equipment.
  • Ability to install, repair, and maintain all mechanical, electrical, pneumatic, and other related components of all manufacturing & packaging equipment in a safe and timely manner.
  • Exhibit good oral and written communication skills, excellent interpersonal skills, and be well organized.
  • Knowledge and understanding of cGMP's.
    • The preferred candidate will have experience in pharmaceutical, medical device or biologic production, engineering, quality assurance, and technical report writing.
    • Prefer working knowledge of ISO 9000 requirements.
  • Computer literate and familiar with Microsoft Excel as well as computerized database systems.

At McGuff Pharmaceuticals, Inc. we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401k retirement plans.

Interested candidates please indicate “Facilities and Maintenance Specialist” on your cover letter or resume and include salary history. Resumes without salary history will not be considered.

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: employment.mpi@mcguff.com

McGuff Pharmaceuticals, Inc. - Maintenance Technician / Mechanic

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has an opening for a Maintenance Technician/Mechanic within our production facility located in Santa Ana, CA. This position reports to the Production Supervisor.

The candidate must be detail-oriented, results-oriented, possess good communication and writing skills, capable of performing assigned production duties and flexible in adapting to changing work priorities.

Duties include:

  • Maintain production equipment by providing troubleshooting, including adjusting, repairing, and replacing components to ensure equipment performance is reliable and meets expectations.
  • Perform preventive, corrective, or emergency maintenance tasks that may require off-shift periods and weekends.
  • Maintain and ensure documentation is accurate, complete and factual as required by policies, procedures, and regulatory guidelines.
  • Document activities to ensure that continuous improvement activities may be implemented where necessary.
  • Work with Engineering and Quality groups in support of qualification/validation of new and existing equipment and processes.
  • Warehousing activities, including stock and supply consumable items utilized within the company.
  • Other varied duties as assigned.

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds and manipulating upwards of 200 lb.

Qualifications include:

  • Education: high school diploma or equivalent
  • Versed in general maintenance activities and safety protocols
  • Competent to perform the duties outlined in the job description and physical requirements

Expectations:

  • Appropriate professional demeanor
  • Ability to work independently
  • Ability to work with others
  • Good communication skills
  • Work with all McGuff employees to foster and promote quality system controls and procedures
  • Knowledge, understanding and compliance with appropriate work SOPs
  • Knowledge, understanding and compliance of the dress code
  • Ability to train to FDA cGMP requirements.
  • Ability to train to ISO 9000 requirements.

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans.

Candidates must be familiar with the job requirements. Direct experience is helpful. Enjoy excellent working conditions. Hours: 7:00 AM – 4:00 PM shift (flexible), M-F with potential weekend/off-shift work. Santa Ana/Costa Mesa area. All applicants must send salary history with current resume. Resumes without salary history will not be considered. Please send resumes and salary history via e-mail to employment.MPI@mcguff.com Attention: Production Supervisor. No telephone calls please.

McGuff Pharmaceuticals, Inc. - Engineering Technician

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for a Engineering Tech within our Manufacturing Division located in Santa Ana, CA. This position reports to the Manager of Product Development.

The Engineering Tech will oversee and be responsible for assigned projects in support of current Manufacturing Process and future Product Lines for McGuff Pharmaceuticals. Responsibilities extend to all activities related to production of current products and development of future generic pharmaceutical dosage forms. The Engineering Tech will work closely with company personnel to ensure that all applicable project objectives, policies, procedures, state and federal laws, and ISO requirements are met.

Duties include:

Responsible for coordinating and implementing activities related to Engineering, Manufacturing, Development and Quality:

  • Revise and/or create Standard Operating Procedures in support of the manufacture of sterile injectable drug prod
  • ucts
  • Obtain working knowledge of current production capabilities through direct training with Manufacturing Operators and Technicians
  • Support/implement the Life-Cycle approach to processes and equipment including developing URS (User Requirement Specifications), FAT, SAT, IQ, OQ and PQ. Requires preparation and execution of the study protocols and reports.
  • Manage assigned engineering projects to include; process design of new systems, product development of generic injectables, etc.
  • Cross-organizational support for the Engineering, Quality, Regulatory, Operations, Production, Maintenance and Facility departments
  • Perform lab and pilot-scale testing as well as scale-up to full-scale commercial manufacturing of new and/or existing product lines
  • Provides technical guidance to department staff as required in areas related to product development such as characterization, pre-formulation, formulation and process development, preparing clinical supplies, and general process improvement.
  • Tech transfer of new systems and processes to production/operations
  • Troubleshooting, failure analysis and corrective action of design and processing errors
  • Prepare CMC section of regulatory submissions (e.g. ANDA)
  • Develop and define material specifications for raw materials (e.g. API, excipients, etc.)
  • Establish vendor relationships in support of equipment, processes, facilities and raw materials
  • Assurance that product development and production activities comply with all regulatory and compliance requirements (e.g. NDA, ANDA, IND, cGMP requirements)
  • Other duties as assigned.

Physical Requirements:

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds.

Qualifications include:

  • Education: Bachelor of Science in Engineering, Chemistry or related field degree. Advanced technical degree is a plus: Masters of Science, or PhD Degree.
  • Hands on ability and strong mechanical aptitude required
  • Minimum of 5 years relevant industry experience.
  • Experience with regulated industry Product Development and Regulatory requirements.
  • Familiar with Chemistry, Engineering and Manufacturing operations.
  • Knowledge of state, federal, and international regulatory requirements and submissions (Federal marketing application such as NDA, ANDA, IND, PMA, etc…) for Pharmaceutical (or medical device) products.
  • Thorough understanding and application of technical principles, theories, and concepts related to product, process, technology development and evaluation.
  • Understanding and working knowledge of chemical and physical properties of pharmaceutical active ingredients and excipients as they relate to formulation, process and drug delivery.
  • Working and theoretical knowledge of pharmaceutical ingredients, manufacturing, processing and testing equipment, advanced technologies, and delivery systems.
  • Ability to develop formulations, processes, and pharmaceutical products.
  • Working understanding of statistical techniques including experimental design.
  • Knowledge of ISO 9000 requirements.
  • Knowledge of FDA requirements (cGMP and marketing applications)
  • Computer literate and familiar with computerized inventory monitoring, tracking and control systems.
  • Type a minimum of 45 words per minute.

Expectations:

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans.

Interested candidates please indicate “Engineering Tech” on your cover letter or resume and include salary history. Resumes without salary history will not be considered. You may send your resume via email to employment.mpi@mcguff.com. No telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: employment.mpi@mcguff.com

McGuff Pharmaceuticals, Inc. - Quality Engineering and Validation Specialist

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has openings for Quality Engineering and Validation Specialist within our Manufacturing Division located in Santa Ana, CA.

The Validation Engineer will work closely with the Quality Engineering and Validation Supervisor to plan, organize and perform commissioning, qualification and validation for defined processes, facilities, equipment and process controls that meet McGuff Pharmaceutical’s high standards.

Description/Primary Responsibilities:

  • Develop and write commissioning, qualification and validation documents following established standards and templates, including but not limited to the following:
    • Commissioning Test Scripts
    • Qualification / Validation Protocols and Summary Reports
    • Standard Operating Procedures
    • Risks / Impact Assessments
    • Specifications (URS/FRS/DDS)
    • FATs / SATs
  • Perform and assist with qualification / validation protocols for projects in compliance with McGuff policies and procedures and industry guidelines in the performance of, such as, IQ/OQ/PQ and other validation activities.
  • Walk down and verification of system drawings (i.e., P&IDs, as-builts, etc)
  • Capable of performing Process Validation, assisting with specification development, and qualifying raw materials, in-process materials and finished goods.
  • Perform various testing procedures as needed for process inputs, outputs and parameters, such as, temperature testing, TOC analysis, LAL, Environmental Monitoring, bioburden testing, sterility testing, chemical analysis, physical analysis, etc… according to written procedures.
  • Working with Quality Engineering Supervisor and Quality Systems staff to troubleshoot, correct and prevent non-conforming products, process, materials, etc…
  • Develop and document written SOPs, as required, for current Good Manufacturing Practices (cGMP).
  • Implementing document changes and control procedures.
  • Conduct deviation investigation and resolution of problems and issues encountered during field execution activities.
  • Preparing and documenting procedures and protocols, including commercial batch record preparation and review.
  • Assisting, coordinating, performing and scheduling material qualifications.
  • Participate in Risk Analysis, as assigned.
  • Coordinating, performing and scheduling calibration activities.
  • Conduct Quality Control testing and monitoring, reviewing and documenting instrumentation output, laboratory record review, and other document control activities.
  • Performing other varied duties, as assigned.

Minimum Requirements:

  • Education: Bachelor of Science in Engineering is required for an Engineer; Bachelor of Science in a related field is required for a Validation Specialist. Non-BS degrees will be evaluated on a case-by-case basis.
  • Minimum of 3-5 years of experience in Pharmaceutical, Biotech, Medical Device, Commissioning or Validation with direct experience in process, equipment, utilities and facility validation. Prefer minimum of 2-3years relevant industry experience with a portion of that experience in manufacturing of sterile injectable drugs via aseptic processing. Experience in writing and execution of OQ, OQ and PQ protocols and reports for GMP Utilities, Equipment, Systems and Software.
  • General exposure and experience in a GMP/Validation discipline with a knowledge and understanding of pharmaceutical Design/Build/Commission/Validation processes and how they relate to regulatory requirements and cGMP regulations within the E.U. and U.S. FDA
  • Proficient with computers and related software (Microsoft Office Professional)
  • Familiarity with related GMP procedures and requirements. Including knowledge of appropriate Quality Systems and cGMP requirements (FDA, EU, ICH) with the ability to assess compliance risks.
  • Familiar with data acquisition systems and protocols. Prefer proficiency with specific data acquisitions systems such as Kaye Validator.
  • Knowledge of validation methodology.
  • Versed in the proper use of statistical techniques and sampling plans.
  • Typing and office-based skills
  • Excellent oral and written communication skills.
  • Excellent interpersonal skills.
  • Ability to work independently and as a team member.
  • Ability to manage multiple concurrent tasks / studies.
  • High energy, enthusiastic self-starter who can work with minimal supervision.
  • Well organized and detail oriented.

The position requires bending, squatting, climbing, and reaching above shoulder level. In addition, the job will require sitting, standing, walking, handling and manipulating objects (manual dexterity and fine finger movement). The position will require repetitively lifting/carrying up to 75 pounds. Ability to perform typing and other, office based, physical requirements are required.

In addition to the minimum requirements, the preferred candidate will have experience in the pharmaceutical manufacturing industry (aseptic fill, small volume, sterile, injectable products), and experience in technical presentations and report writing. Certifications preferred (e.g. ASQ CQE or CRE).

At McGuff Pharmaceuticals, Inc. we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401k retirement plans.

Interested candidates please indicate “Quality Engineering and Validation Specialist ” on your cover letter or resume. You may either send your resume via email to employment.mpi@mcguff.com. No fax or telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: employment.mpi@mcguff.com

McGuff Pharmaceuticals, Inc. - Regulatory Affairs Analyst

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered and ISO 9001 certified company with a reputation for outstanding commitment to quality and customer satisfaction.

As a dedicated member of the healthcare community, we have openings for individuals willing to work in a dynamic and challenging environment that is designed to provide opportunities for personal growth and development. Join us as we continue to improve our current products as well as identify and develop new product lines under a quality system designed to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has an opening for a Regulatory Affairs Analyst within our Manufacturing Division located in Santa Ana, CA. This position reports to the Senior Regulatory Affairs Specialist.

The Regulatory Affairs Analyst will oversee and be responsible for assigned Product Development projects for McGuff Pharmaceuticals. Responsibilities extend to all activities related to product development of pharmaceutical dosage forms. The Regulatory Affairs Analyst will work closely with company personnel to ensure that all applicable project objectives, policies, procedures, state/federal/international laws, and ISO requirements are met.

Duties shall include:

Responsible for coordinating and implementing activities related to future and ongoing product development including:
  • Regulatory Affairs support of the product development process, submissions and regulatory compliance.
  • Act as a company representative, developing and maintaining positive relationships with outside consultants and regulators through oral and written communications.
  • Maintain site registrations and licenses.
  • Develop/revise/implement departmental policies and procedure affecting regulatory affairs and compliance.
  • Develop/revise/implement regulatory affairs and compliance training to cross functional groups.
  • Help develop and implement regulatory strategies for new and current pharmaceutical products.
  • Act as a core member on manufacturing and development teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
  • Preparation and submission of regulatory applications, as well as internal regulatory file documentation.
  • Review product labeling and advertising materials for compliance with global submissions and applicable regulations; analyze and recommend appropriate changes.
  • Review and sign-off on product and manufacturing changes for compliance with applicable regulations.
  • Participate in internal audit programs
  • Participate in Corrective/Preventative Actions for processing deviations and material reviews, as necessary.
  • Participate and provide guidance for all aspects of company business that require regulatory insight and understanding.
  • Other duties as assigned.

Physical Requirements:

The position is a professional administrative position.

Qualifications Include:

  • Education: Bachelor of Science/Arts degree, preferably in a scientific or technical discipline, or comparable additional experience. RAPS Regulatory Affairs Certification (RAC-US, RAC-EU) is desirable.
  • Minimum of 5 years relevant industry experience with Regulatory Affairs and Quality Assurance/Quality Control of Pharmaceutical manufacturing and clinical trials.
  • Understanding of FDA and international regulations.
  • Knowledge of ISO 9000 requirements.
  • Knowledge of FDA cGMP requirements.
  • Knowledge of NDA and ANDA product applications and approval with FDA.
  • Preferred candidate will have direct experience with successful filing of domestic and international marketing applications for injectable pharmaceuticals.
  • Knowledge of domestic and international product compliance requirements.
  • Knowledge of clinical trial strategy and study design, statistical methods and data reporting preferred.
  • Computer literate and familiar with computerized documentation and database methods, tracking and control systems.
  • Ability to manage multiple projects.
  • Effective research and analytical skills.
  • Excellent written and oral communication, technical writing and editing skills.

Expectations

  • Appropriate professional demeanor.
  • Acquire knowledge of and assure compliance to corporate policies and procedures.
  • Ability to work with others.
  • Excellent communication skills.
  • Work with all McGuff employees to foster and promote quality.
  • Excellent customer skills
  • High regard for Trust, Integrity, Honesty, Ethics, Innovations and Safety in self and others.
  • High sense of Responsibility, Ownership, Accountability.
  • Capable of Flexibility in work requirements/conditions and willingness to embrace change
  • Results driven and a hands on approach to completion of assigned tasks

At McGuff Pharmaceuticals, Inc., we offer excellent compensation and benefits programs that reflect our goal to be a competitive and supportive employer. McGuff Pharmaceuticals, Inc. provides a comprehensive benefits package that includes medical, dental, and 401K retirement plans.

Interested candidates please indicate “Regulatory Affairs Analyst” on your cover letter or resume and include salary history. Resumes without salary history will not be considered. Please send resumes and salary history via e-mail to employment.mpi@mcguff.com Attention: Senior Regulatory Affairs Specialist. No telephone calls please.

Additional Information:

Salary: Open
Position Type: Full Time
Contact Information: employment.mpi@mcguff.com

Our Commitment to Our Employees:

Health and safety

McGuff will do all that is reasonable and practicable to protect the health and safety of its employees.

Healthcare insurance

McGuff will treat its employees as family and will make every effort to maintain free healthcare insurance not only to each employee but to each of the employee’s dependents as well.

Equal and fair treatment

Every employee has equal opportunities and will be treated equally in employment and occupation regardless of personal background, race, gender, nationality, age, sexual preference or religious belief. The same applies to the recruitment of employees. McGuff strives to offer equal pay for equal work performed at equal levels at similar locations. No form of harassment or discrimination will be tolerated.

Wages and payment

Remuneration and working hours shall comply with local labor laws and shall at least be in line with prevailing industry norms.

Retirement benefits

McGuff recognizes the importance of each employee’s contribution to the labors of the company and desires that each employee be compensated in such a manner as to promote long-term employment and retirement benefits.

McGuff Named One of Orange County Register's Top Workplaces of 2014

McGuff Named One of Orange County Register's Top 100 Workplaces of 2014 and 2015


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