GMP QA Specialist – On-the-Floor Batch Oversight

Eurofins; Sanford (NC); On-site; USD 65,000 - 85,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Life and Disability Insurance

401(k) with company match

Paid vacation and holidays

Job summary

Eurofins USA PSS Insourcing Solutions is seeking a Manufacturing QA Associate to support quality assurance on the floor for drug substance manufacturing in Sanford, NC.

You will perform real-time review of batch records, ensure GMP compliance, and contribute to investigations, deviations, and cross-functional initiatives. This is a full-time role with comprehensive benefits and regular weekday hours.

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 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.

Responsibilities

• Use fundamental knowledge of GMP and established procedures to provide quality oversight of manufacturing documentation and GMP compliance.
• Contribute to Quality oversight activities and foster a culture of quality across all functions.
• Execute real time review of batch documentation and other manufacturing documentation for errors 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 timelines.
• Execute or review room and line clearances.
• Make quality decisions in real-time according to regulations (ICH Q7, 21CFR211).
• Support/initiate analytical test results initial investigation on the floor.
• Review and may approve manufacturing analytical testing on the floor.

Skills

GMP Knowledge

Quality Assurance

Documentation Review

Deviation Investigations

Cross-functional Collaboration

Batch Records Review

Education

Bachelor's in Microbiology or related field

Master's degree (optional)

Job description

Eurofins USA PSS Insourcing Solutions is seeking a Manufacturing QA Associate to support quality assurance on the floor for drug substance manufacturing in Sanford, NC.

You will perform real-time review of batch records, ensure GMP compliance, and contribute to investigations, deviations, and cross-functional initiatives. This is a full-time role with comprehensive benefits and regular weekday hours.