GMP Compliance Investigator: Equipment & Facilities Expert

Eightelevengroup; Durham (NC); On-site; USD 90,000 - 120,000; Full time

Job summary

Medasource seeks a GMP Compliance Investigator – Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This hands-on role leads investigations, authors quality documentation, and partners with Manufacturing and Quality teams to ensure FDA and accreditation standards are met.

You will develop SOPs, manage deviations, CAPAs, and change controls; author IQ/OQ/PQ validation documents; and assist during inspections.

Qualifications

• Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.
• Minimum of 6 years of QA, Quality Systems, or GMP Compliance experience in a regulated manufacturing environment.
• Master's degree may substitute for two years of experience.

Responsibilities

• Develop, revise, and maintain SOPs to ensure FDA regulatory compliance.
• Author and manage change controls related to SOP updates and manufacturing process improvements.
• Edit batch records and manufacturing documentation as needed.
• Initiate, investigate, author, and close deviations, CAPAs, investigations, and quality memos.
• Partner with Manufacturing and Quality teams to investigate manufacturing events and drive timely closure of quality records.
• Serve as the primary author for equipment and facility-related deviation investigations.
• Attend meetings with equipment vendors and internal stakeholders to gather information supporting investigations.
• Author validation documentation, including IQ, OQ, and PQ protocols, equipment assessments, and validation reports.
• Manage deviation, CAPA, and change control timelines to support on-time batch release.
• Perform failure mode analysis and root cause investigations.
• Assist during FDA, accreditation, sponsor, and regulatory inspections, including responses to audit observations.

Skills

Quality Assurance

GMP Compliance

Technical Writing

Investigation Skills

Cross-functional Collaboration

Education

Bachelor's degree in Biology or Life Sciences

Master's degree may substitute for 2 years experience

Tools

QMS software

Job description

Medasource seeks a GMP Compliance Investigator – Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This hands-on role leads investigations, authors quality documentation, and partners with Manufacturing and Quality teams to ensure FDA and accreditation standards are met.

You will develop SOPs, manage deviations, CAPAs, and change controls; author IQ/OQ/PQ validation documents; and assist during inspections.