Quality Manager (Costa Mesa, CA, $90K - $120K)

SNAPSHOT!

Looking to join one of the leading and most exciting parenteral drug product manufacturing and analytical service providing companies in Southern California for pharmaceutical and biotech industries? READ ON!! In this critical position you would be responsible for training and managing Commercial Scale QA personnel, designing, and implementing QA programs, and ensuring that all GMP requirements are satisfied. The Quality Manager will report directly to the Director of Quality and supervise the Quality Assurance Specialist and support staff as project or work conditions require.

Immediate opening for a Quality Manager in Costa Mesa, CA who possesses:

• Bachelor's or Master’s degree in Chemistry, Biology, or related scientific discipline and a minimum of seven (7) to ten (10) years of managerial experience in an aseptic manufacturing GMP environment.

• Experience in a CMO environment is preferred.

• Demonstrated ability to effectively supervise and direct personnel and to plan and direct medium to large projects.

• Oral and written communication skills must be at a level appropriate for effective in-house communications, client contact, and report preparation.

KEY RESPONSIBILITIES INCLUDE:

• Ability to set-up, maintain, and perform various manufacturing-related quality control/assurance activities as required for a GMP compliant Fill/Finish operation.

• Develop protocols in compliance with IQ/OQ/PQ requirements and industry guidelines as related to quality control/assurance manufacturing activities.

• Develop SOPs for all quality-related activities as required for a GMP compliant Fill/Finish operation.

• Oversee the contract manufacturing facility for compliant release of final products. This includes but is not limited to batch records review and approval.

• Lead the timely resolution and successful closure of deviations/CAPAs/Investigations, and NCRs.

• Design and implement protocols to validate and monitor the various quality, manufacturing activities, or systems, such as WFI, air handling, etc., in compliance with industry guidelines.

• Ability to manage vendor, client, and FDA audits, and initiate the appropriate documentation required.

• Train and supervise all subordinate employees for all quality control/assurance activities within manufacturing areas.

• Perform all duties and all quality control/assurance activities according to the applicable guidelines, i.e. FDA, GMP, and ICH, etc.

• Perform various quality duties and initiate appropriate documentation as required.

• Oversee other QA processes such as receipt and release of raw materials and automation activities, and management of other ongoing projects.

• Oversee the Environmental Monitoring program for the manufacturing facility.

• Ability to perform technical evaluation of quality control/assurance related information and provide management with status reports including information required for decision-making purposes.

• Ability to initiate problem-solving and technical decision-making commensurate with the level of experience.

• Perform other related duties and responsibilities as assigned.

If you’d like to explore, send your resume to admin@snapstaffing.com and we’ll follow up with you ASAP!