GMP Compliance Investigator

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

GMP Compliance Investigator – Equipment & Facilities

Overview

Our client is seeking a GMP Compliance Investigator – Equipment & Facilities to support a GMP manufacturing laboratory focused on advanced cellular therapies. This individual will play a key role in maintaining compliance with FDA regulations and applicable accreditation standards by leading investigations, authoring quality documentation, and partnering closely with Manufacturing and Quality teams.

This is a highly collaborative role for someone with strong GMP quality experience, exceptional technical writing skills, and the ability to manage complex investigations from initiation through closure.

Responsibilities

• Develop, revise, and maintain Standard Operating Procedures (SOPs) to ensure compliance with FDA and applicable regulatory requirements.


• 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.


• Support batch release activities from a compliance perspective.


• Ensure compliance with FDA regulations and applicable accreditation standards.


• Train and educate personnel on updated procedures, SOPs, quality systems, and compliance requirements.


• Assist during FDA, accreditation, sponsor, and regulatory inspections, including responses to audit observations.


• Monitor Quality Agreements to ensure sponsor notification requirements are met.


• Participate in continuous improvement initiatives to optimize quality systems and documentation processes.

Preferred Qualifications

• Experience working in a Quality Assurance or GMP Compliance function within an FDA-regulated manufacturing environment.


• Experience supporting deviations, investigations, CAPAs, and change controls.


• Strong technical writing skills with experience authoring investigation reports and SOPs.


• Experience participating in FDA inspections, regulatory audits, and sponsor audits.


• Experience with electronic Quality Management Systems (QMS).


• Project management experience.


• Strong analytical and root cause investigation skills.


• Excellent written and verbal communication skills.


• Strong organizational skills with exceptional attention to detail.


• Ability to work independently while collaborating effectively across cross-functional teams.

Minimum Qualifications

Education

• Bachelor's degree in Biology, Life Sciences, or a related scientific discipline.

Experience

• Minimum of 6 years of Quality Assurance, Quality Systems, or GMP Compliance experience within a regulated manufacturing environment.


• A Master's degree in a related field may substitute for two years of experience.

Location

Durham, North Carolina

Medasource is an equal opportunity employer that does not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, lactation and related medical conditions), gender identity or gender expression, sexual orientation, marital status, military service and veteran status, physical or mental disability, protected medical condition as defined by applicable state or local law, genetic information, or any other characteristic protected by applicable federal, state, or local laws and ordinances.

Benefits & Perks

• Medasource offers competitive medical, dental, vision, Health Savings Account, Dependent Care FSA, and supplemental coverage with plans that can fit each employee’s needs.


• We offer a 401k plan that includes a company match and is fully vested after you become eligible, paid time off, sick time, and paid company holidays.


• We also offer an Employee Assistance Program (EAP) that provides services like virtual counseling, financial services, legal services, life coaching, etc.

Pay Disclaimer

The pay range for this job level is a general guideline only and not a guarantee of compensation or salary. Additional factors considered in extending an offer include (but are not limited to) responsibilities of the job, education, experience, knowledge, skills, and abilities, as well as internal equity, alignment with market data, applicable bargaining agreement (if any), or other law.