GMP Compliance Investigator

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.