GMP Compliance Investigator

Medasource; Durham (NC); In loco; USD 90.000 - 130.000; Tempo pieno

Descrizione del lavoro

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

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical skills

Root cause analysis

Technical writing

Project management

Communication skills

Formazione

BSc Life Sciences

MS degree substitution for experience

Strumenti

QMS software

Descrizione del lavoro

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.

Eperience

• 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.