Manufacturing QA Associate (2nd Shift)

Job Description

The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing.

• Use fundamental knowledge of GMP, and established procedures methodologies to provide quality oversight of manufacturing documentation, housekeeping, and overall GMP compliance

• Ensure the site performs in a state of compliance by contributing to Quality oversight activities while fostering an empowered culture of quality across all functions

• Execute real time review of batch documentation and other manufacturing documentation analyzing for errors, corrections, and compliance

• Support Transfer Master Cell Banks to Manufacturing

• Perform housekeeping and GMP walkthroughs of facility

• Initiate deviations in real-time and assist in investigations

• Work in cross-functional teams to meet and exceed timelines

• Execute or review room and line clearances

• Make quality decisions in real-time according to regulations ICH Q7 and 21CFR211 and internal procedures

• Support/initiate analytical test results initial investigation on the floor

• Reviews and may approve manufacturing analytical testing on the floor

Qualifications

• Bachelor's degree and 2-4 years of relevant experience or a Master's degree and up to 2 years of relevant experience

• Quality Assurance in GMP facilities, drug substance preferred

• Batch record review, housekeeping monitoring, GMP document review and/or creation.

• Reviewing deviation reports, change controls, CAPA, and analytical data.

• Experience with Data Integrity

• Knowledge of and experience in GMP, following applicable regulations, or willingness to become GMP proficient

Additional Information

This position is Full-Time, Tuesday-Saturday 3pm-12am . Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

• Excellent full-time benefits including comprehensive medical coverage, dental, and vision options

• Life and disability insurance

• 401(k) with company match

• Paid vacation and holidays

Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.