Careers

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 an Engineer within our Manufacturing Division located in Santa Ana, CA. This position reports to the Plant Manager.

The Engineer will oversee and be responsible for assigned Engineering projects for McGuff Pharmaceuticals. Responsibilities extend to all activities related to facility expansion, equipment/process design, installation and operational qualifications, process development and product development in a pharmaceutical environment. The Engineer will work closely with company personnel to ensure that all applicable project objectives, policies, procedures, state and federal laws

Duties shall include:

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

• Implementing departmental policies, programs and procedures within the engineering group
• Plan, organize and lead engineering projects; including identifying goals, objectives, methods, resources, and routes of communication needed to carry out responsibilities and dates for completion of engineering activities and tasks.
• Organizing resources to achieve the goals within a defined timeline.
• Establishing effective communications and guiding project members to accomplish stated project objectives.
• Meeting strategic objectives for company growth.
• Support both Processes Development and Product Development for generic sterile injectables
• Prepare engineering documentation for equipment procurement (e.g. URS, DDS, FAT, SAT) as well as equipment installs (e.g. IQ, OQ) and process validations (e.g. Cleaning Qualifications, Process Qualifications)
• Develop and define product specifications, procedures, and controls.
• Provide technical guidance to department staff as required in areas related to engineering and process 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 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 Plant Manager, working with customers and clients to define and implement contract manufacturing opportunities to meet customer requirements and exceed expectations.
• As assigned by the Plant 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 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 “Engineer” on your cover letter or resume. Please send resumes via e-mail to employment@mcguff.com Attention: Plant Manager. No telephone calls please.

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

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 preferred. Enjoy excellent working conditions.

Salary: Open 
Contact Information: employment.mpi@mcguff.com

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed, FDA registered pharmaceutical manufacturing 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 facility to exceed customer expectations.

McGuff Pharmaceuticals, Inc. currently has an opening for a hands-on Quality Assurance Technician within our Quality Systems department located in Santa Ana, CA.

Description/Key Responsibilities:

• Performing work within the Quality Systems, as assigned. Examples include support in areas such as supplier qualification, internal audits, Material Review Board, customer complaints, CAPA, non-conformance investigations and follow-up, Risk Analysis, maintaining external standards, process monitoring, training, returned goods processing, and regulatory and customer audits.
• Reviewing production batch and other manufacturing records to assure compliance to established procedures.
• Planning and conducting internal audits, preparing reports, presenting audit findings.
• Performing inspections of operational non-conformances, preparing reports.
• Performing supplier qualifications via completion of surveys, information gathering, Quality Agreements, preparation of related reports.
• Performing material control actions including Material Review Board support, material qualifications, support incoming material inspections, material disposition.
• Performing process controls actions including CAPA, Risk Analysis.
• Supporting product complaint investigations, returned goods processing.
• Performing customer interactions including answering customer inquiries via telephone.
• Supporting Operations during performance of regulatory inspections by external agencies such as FDA and customer audits.
• Writing new and revising existing Standard Operating Procedures and perform related training.
• Maintaining records and databases as assigned.
• Supporting other departments in the areas of equipment calibrations, process validations and other areas as assigned.
• Other varied duties as assigned.

Minimum Requirements:

• Well organized and detail oriented.
• The employee must bend, squat, climb, reach above shoulder level, sit, stand, walk, handle objects (manual dexterity), and use the finger movement. On the job employees repetitively lift/carries up to 75 pounds.
• Education: Bachelor of Science degree in related field or comparable additional experience.
• Strong computer skills including MS Word, Excel, Access and PowerPoint.
• Versed in the proper use of statistical techniques and sampling plans.
• Excellent oral and written communication skills.
• Excellent interpersonal skills.
• High energy, enthusiastic self-starter who can work with minimal supervision.
• Able to lead/work in teams as well as independently.

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

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.

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

The McGuff family of companies is dedicated to meeting our customer’s needs. Our mission is to provide the highest quality pharmaceuticals so that people around the world may benefit from the restorative, healing and medicinal properties provided by our products. McGuff Pharmaceuticals, Inc. is an FDA registered pharmaceutical manufacturing company with a reputation for outstanding commitment to quality and customer satisfaction.

McGuff Pharmaceuticals, Inc. currently has an opening for a Microbiology Technician working in our Quality Systems Laboratory within our manufacturing division located in Santa Ana, CA. The qualified candidate must be detail-oriented, results-oriented, capable of performing assigned laboratory duties, flexible in adapting to changing work priorities, and must possess good communication and writing skills.

In addition, our Microbiology Technician will perform test services to support McGuff Pharmaceuticals, Inc. and our sister division, McGuff CPS, Inc. McGuff CPS prepares custom prescription compounds for physicians and their patients. McGuff CPS is a California Pharmacy, licensed to compound all forms of prescription medications, including sterile, injectable compounds.

The Microbiology Technician will be responsible for (1) Verifying that materials and products comply with microbial and/or chemical specification limits (2) Conducting laboratory testing in support of operations, (3) Maintain the laboratory operations in compliance with McGuff policies, federal regulations, state regulations, and international standards, (4) Maintain documentation, calibration, and validation of all microbial equipment, (5) conduct other duties as assigned by the laboratory supervisor and/or Microbiologist.

Duties shall include:

• Perform lab work as needed: Environmental Monitoring, Bioburden, Endotoxin testing (LAL), Sterility testing, chemistry analysis (cross train) according to written procedures, etc…
• Documenting work according to cGMP/cGLP requirements.
• Keep files of all microbial/chemical tests performed; maintain log book of all samples received for analysis.
• Other QC activities to support manufacturing and pharmacy operations, as assigned.
• Ordering and stocking laboratory supplies and materials.
• Preparing laboratory materials, glassware, and equipment for use.
• Ensure samples delivered to the laboratory are controlled and methods applied are as required and valid.
• Conduct/coordinate the repair/maintenance of laboratory equipment.
• Other responsibilities: filing, typing letters, customer follow up, working with other people in the office (e.g. purchasing, accounts receivable, accounts payable, warehousing, etc…).
• Other varied duties as assigned.

Physical Requirements:

The employee must bend, squat, climb, reach above shoulder level, sit, stand, walk, handle objects (manual dexterity), and use fine finger movement. On the job employees may be required to lift/carry up to 50 pounds and manipulate up to 100 pounds.

Qualifications include:

• Education: Bachelor of Science degree in related field or comparable additional experience.
• Experience: 0 to 5 years related industry experience.
• Prefer Knowledge of FDA cGMP requirements
• Prefer Experience in QA/QC of sterile drug products produced by aseptic processing
• Proficient with computers and related software (Microsoft Office Professional).

Additional Information:

Our outstanding benefits program includes medical, dental, 401k and generous paid time off (PTO) program.

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

McGuff Pharmaceuticals, Inc. (a subsidiary of McGuff Company, Inc.) is a licensed pharmaceutical manufacturer, FDA registered 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 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
• Forklift operator training (will train and certify)
• Proficient in speaking, reading, and writing English.
• Knowledge of FDA cGMP 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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 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 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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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.

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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 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 products
• 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 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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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. (a subsidiary of McGuff Company, Inc.) is an FDA registered 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 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 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