Are you looking to join a company that has an outstanding history of developing and producing biodefense and lifesaving drugs and has signed deals with some of the largest drug development companies to manufacture the next COVID vaccine? A company where you feel a sense of ownership in your future? If so, look no further.

Our client is looking to hire a Specialist, QA on the Floor Production

Job Summary:

The Specialist I for QA on the Floor is responsible for assuring the quality of products manufactured and performing Quality on the Floor functions. The QA Department provides expertise in problem-solving and process improvements. The QA Specialist will interact with manufacturing personnel and Quality Engineers to provide guidance necessary to maintain and improve CGMP compliance at the company.

This will be a 3rd shift (10:00 p.m. to 6:30 a.m.) Monday thru Friday position. Overtime and weekend work required as needed based on manufacturing needs.

Responsibilities include but are not limited to:

• Performance of walkthroughs of GMP areas to ensure inspection readiness of facility is maintained; includes documentation, follow-up and escalation of observations, and areas of concern
• Write, reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking and follow-up plans
• Reviews and approves CGMP documents such as batch records, engineering runs, work orders, logbooks, and reports to ensure compliance with specifications, regulations, and procedures
• Train and mentor Production personnel on manufacturing processes to resolve open issues resulting from record reviews, on the floor walkthroughs, and deviation issues

Experience & Skills:

• BS or BA degree in Science or Engineering with 5-10 years of GMP experience
• Ability to use computer programs such as eDocs and SAP