GMP Compliance Investigator - Equipment & Facilities Lead

Medasource; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Medasource in Durham, NC is seeking a GMP Compliance Investigator - Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. You will lead investigations, author quality documentation, and collaborate with Manufacturing and Quality to uphold FDA regulations and accreditation standards.

This highly collaborative role requires strong GMP quality experience and exceptional technical writing skills, with responsibility from initiation through closure

Qualifications

• Experience in QA/GMP compliance within an FDA-regulated environment.
• Experience supporting deviations, investigations, CAPAs and change controls.
• Strong technical writing for investigation reports and SOPs.
• Experience with FDA inspections and sponsor audits.
• Familiarity with electronic QMS systems.

Responsibilities

• Develop, revise, and maintain SOPs to ensure FDA compliance.
• Author and manage change controls for SOP updates and process improvements.
• Edit batch records and manufacturing documentation as needed.
• Initiate, investigate, author, and close deviations, CAPAs, investigations, and memos.
• Partner with Manufacturing and Quality teams to investigate events and close records.
• Primary author for equipment- and facility-related deviation investigations.
• Attend meetings with equipment vendors and internal stakeholders.
• Author validation docs, including IQ, OQ, PQ protocols and reports.
• Manage deviation, CAPA, and change-control timelines for on-time batch release.
• Perform failure mode analysis and root cause investigations.
• Support batch release activities from a compliance perspective.
• Ensure FDA regulations and accreditation standards compliance.
• Train personnel on updated procedures and quality systems.
• Assist during FDA inspections and responses to audit observations.
• Monitor Quality Agreements for sponsor notification requirements.
• Participate in continuous improvement initiatives.

Skills

Analytical skills

Root cause analysis

Technical writing

Project management

Communication skills

Education

BSc Life Sciences

MS degree substitution for experience

Tools

QMS software

Job description

Medasource in Durham, NC is seeking a GMP Compliance Investigator - Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. You will lead investigations, author quality documentation, and collaborate with Manufacturing and Quality to uphold FDA regulations and accreditation standards.

This highly collaborative role requires strong GMP quality experience and exceptional technical writing skills, with responsibility from initiation through closure