Pharmaceutical 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 operations and processes 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 Pharmaceutical Engineer within our Manufacturing Division located in Santa Ana, CA.

Description/Key Responsibilities:

• Support drug product process development.
• Learn and conduct compounding and filling operations to gain line-level knowledge and insights into our processes and procedures.
• Coordinate studies required for product development projects.
• Plan, implement, conduct, and report on qualification and validation of processes, equipment, and facilities including authoring technical protocols and reports.
• Coordinate documentation required for process implementation and changes associated with new product introductions.
• Makes engineering recommendations and implements solutions.
• Select, design, and implement new or replacement process technology.
• Develop a complete and detailed understanding of current production processes. This will include direct hands on training and performance of production activities such as container/closure processing, filling, capping, compounding, etc…
• Reviews historical data of existing process equipment or product performance on a regular schedule basis.
• Resolve production process and equipment issues through established process improvement systems.
• Any and all other duties as assigned by immediate supervisor.

The Engineer will provide technical support to the product development team in developing drug products and manufacturing processes. Such product development will require applying fundamental engineering principles and hands-on knowledge of manufacturing processes to new products, process, and development technologies. The Engineer will participate in activities through all phases of development including concept design, lab scale testing, pilot scale development, and process transfer to full scale production.

Other responsibilities will include resolving technical issues with the current manufacturing processes/equipment and hands on participation in ongoing manufacturing activities. In addition, the Engineer will support manufacturing operations through trending analysis, identifying potential areas for improvement, defining corrective and preventive actions, etc…

Minimum Requirements:

• Bachelor of Science degree in Engineering (chemical or mechanical preferred) or a related scientific discipline.
• The preferred candidate will have a minimum of 5 years of direct work experience in the Pharmaceutical industry with an emphasis in supporting product development or manufacturing of drug products. This will include knowledge and understanding of cGMPs, experience in Engineering and pharmaceutical production/development, and good technical writing skills. The individual must exhibit good oral and written communication skills, excellent interpersonal skills, be well-organized and able to work in teams as well as independently. Demonstrate hands on technical ability.

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 and include salary history. Resumes without salary history will not be considered. You may either fax your resume to (877) 444-1155 or send via email to chris@mcguff.com. No telephone calls please.

Quality Operations Specialist

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.

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 operations and processes 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 hands-on Quality Operations Specialist within our Manufacturing Division located in Santa Ana, CA. This position reports directly to the Vice President and Director of Operations.

Description/Key Responsibilities:

• Responsible for Quality Assurance activities related to our pharmaceutical manufacturing operations for key sterile injectable product lines.
• Plan, direct and perform QA functions to maintain compliance with FDA and company standards.
• Conduct QA Investigations and prepare reports as required regarding issues identified under the non-conformance management system and environmental monitoring system, including database management.
• Manage and administer the Customer Complaints System and Database. Conduct complaint investigations and prepare reports on customer complaints to management.
• Development and implement effective corrective and preventative actions, as assigned.
• Assist with planning, coordinating, and conducting qualifications and validations for targeted products/processes.
• Support the efforts of the organization in meeting applicable regulation and requirements, specifically (but not limited to) maintaining FDA cGMP compliance, certification to ISO9001 standards, implementation of internal audits, coordinating corrective and preventative actions, coordinating MRB, and training programs.
• Conduct internal quality audits to identify the causes of deficiencies and ensure effective corrective action is implemented.
• Support production monitoring activities and evaluations to determine control over applicable variables.
• Prepare periodic presentations for management and staff for improvement of Quality System and controls.
• Manage miscellaneous projects and support overall company objectives, as assigned.

The Engineer will provide technical support to the product development team in developing drug products and manufacturing processes. Such product development will require applying fundamental engineering principles and hands-on knowledge of manufacturing processes to new products, process, and development technologies. The Engineer will participate in activities through all phases of development including concept design, lab scale testing, pilot scale development, and process transfer to full scale production.

Other responsibilities will include resolving technical issues with the current manufacturing processes/equipment and hands on participation in ongoing manufacturing activities. In addition, the Engineer will support manufacturing operations through trending analysis, identifying potential areas for improvement, defining corrective and preventive actions, etc…

Minimum Requirements:

• Well organized and detail oriented.
• Bachelor's of Science degree in a related scientific discipline (Microbiology, Chemistry or Engineering).
• Minimum of 7 years relevant industry experience.
• Knowledge and understanding of cGMP's is required. Strong understanding of FDA regulation requirements, preferably with experience dealing with FDA.
• Strong computer skills including MS Word, Excel, Access and PowerPoint.
• 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), direct experience in FDA pre-market applications (IND, ANDA, NDA), Microbiology/Chemistry laboratory methods, strong mechanical aptitude, and experience in technical presentations and report writing. Certifications preferred (e.g. CQE or CRE).M

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 Operations Specialist” 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 alicia@mcguff.com. No telephone calls please.

Microbiology Technician

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 production 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 the finger movement. On the job employees repetitively lift/carries up to 50 pounds.

Qualifications include:

• Education: Bachelor of Science degree in related field or comparable additional experience.
• Experience: 2 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
• Prefer Knowledge of ISO 9000 requirements.
• Proficient with computers and related software (Microsoft Office Professional).

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 “Microbiology Technician” 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 e-mail to the contact indicated below. No telephone calls please.