Manufacturing QA Associate (2nd Shift)

About the role

The Manufacturing QA Associate contributes to Quality Assurance on the floor activities related to drug substance manufacturing. Candidates currently living within a commutable distance of Sanford, NC are encouraged to apply.

Responsibilities

• Use fundamental knowledge of GMP and established procedures 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 the 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.
• Review and may approve manufacturing analytical testing on the floor.

Qualifications

• Bachelor's Degree in Microbiology or related field (e.g., microbiology, chemistry, biological sciences, bioengineering, etc.).
• 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 experience 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.

Benefits

• Comprehensive medical coverage.
• Dental and vision options.
• Life and disability insurance.
• 401(k) with company match.
• Paid vacation and holidays.

Schedule

Full‑Time, Monday‑Friday 3 pm‑12 am.