Manufacturing QA Associate (2nd Shift)

Company Overview

Eurofins Scientific is an international life sciences company providing a unique range of analytical testing services to clients across multiple industries to make life and the environment safer, healthier, and more sustainable. The Eurofins network is the global leader in food, environment, pharmaceutical and cosmetic product testing, agroscience contract research, genomics, discovery pharmacology, forensics, advanced material sciences, clinical study support, and emerging contract development and manufacturing services. With over 30 years of growth, Eurofins now employs 58,000 staff in 900 laboratories across 54 countries, offering a portfolio of more than 200,000 analytical methods.

Responsibilities

• Contribute to Quality Assurance on the floor activities related to drug substance manufacturing.
• 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 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 of 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 ICH Q7, 21 CFR 211, 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 a related field (e.g., chemistry, biological sciences, bioengineering) – or a Master’s degree with up to 2 years of relevant experience.
• 2–4 years of relevant experience with a Bachelor’s degree, or up to 2 years with a Master’s degree.
• Quality Assurance experience in GMP facilities, preferably drug substance manufacturing.
• Experience with batch record review, housekeeping monitoring, GMP document review/creation, deviation reports, change controls, CAPA, and analytical data.
• Knowledge of data integrity principles.
• Familiarity with GMP regulations (ICH Q7, 21 CFR 211) or willingness to become GMP proficient.

Schedule

Full‑time, Monday – Friday, 3 pm – 12 am. Candidates must reside within a commutable distance of Sanford, NC.

Benefits

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