Actalent
2 days ago Be among the first 25 applicants
Get AI-powered advice on this job and more exclusive features.
Actalent is seeking an experienced GMP Auditor to support internal, external, and supplier audits in compliance with global regulations and standards (FDA, EMA, MHRA, Health Canada, ISO 13485, ICH, and 21 CFR Parts 210/211, 820, and 11). You will evaluate quality systems, manufacturing processes, laboratories, and distribution operations to ensure compliance, identify risks, and drive continuous improvement. This role requires strong knowledge of both drug and device regulatory frameworks and the ability to communicate findings effectively with cross-functional teams and external partners.
Key Responsibilities
Plan, prepare, and conduct internal audits, supplier/vendor qualification audits, and regulatory inspection readiness assessments across drug and device operations. Evaluate compliance with GMP, GLP, GCP (where applicable), ISO 13485, and other relevant regulations/guidelines. Assess quality management systems (QMS), including: Documentation and records management Deviation, CAPA, and change control systems Training and qualification programs Data integrity and electronic system compliance (21 CFR Part 11, Annex 11) Audit manufacturing, packaging, labeling, testing, warehousing, and distribution operations for adherence to regulatory requirements. Review process validation, equipment qualification, method validation, cleaning validation, and sterility assurance activities. Identify audit observations, classify findings (critical/major/minor), and prepare clear and objective audit reports. Follow up on CAPA implementation and verify effectiveness checks. Provide inspection readiness support for FDA, EMA, MHRA, Health Canada, and other health authority inspections. Collaborate with QA, Regulatory Affairs, Manufacturing, and Supply Chain to ensure a culture of compliance and continuous improvement. Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related field. Minimum 5+ years of experience in GMP auditing within the pharmaceutical and/or medical device industry. Strong knowledge of FDA 21 CFR Parts 210/211 (Drugs), 820 (Devices), Part 11 (Electronic Records), EU GMP Guidelines, ISO 13485, ICH Q-series, and related standards. Demonstrated experience in conducting audits of CMOs, CROs, laboratories, and suppliers. Excellent understanding of quality systems, risk management, and data integrity principles. Strong analytical, problem-solving, and report-writing skills. Ability to work independently and manage multiple audits across global sites. Professional auditor certification (e.g., ASQ CQA, RQAP-GCP, ISO Lead Auditor) is a plus. Additional Skills & Attributes
Strong attention to detail and ability to assess complex processes. Effective communication and presentation skills (verbal & written). Ability to build rapport with auditees and maintain professional objectivity. Critical thinking with a risk-based mindset. Flexibility to travel (domestic and international) up to 25–50% as required. Remote role with travel to client sites as needed to complete audits. Collaborate with cross-functional teams and external partners. Seniority level
Associate Employment type
Part-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing Pharmaceutical Manufacturing Location: Parsippany, NJ
#J-18808-Ljbffr
Plan, prepare, and conduct internal audits, supplier/vendor qualification audits, and regulatory inspection readiness assessments across drug and device operations. Evaluate compliance with GMP, GLP, GCP (where applicable), ISO 13485, and other relevant regulations/guidelines. Assess quality management systems (QMS), including: Documentation and records management Deviation, CAPA, and change control systems Training and qualification programs Data integrity and electronic system compliance (21 CFR Part 11, Annex 11) Audit manufacturing, packaging, labeling, testing, warehousing, and distribution operations for adherence to regulatory requirements. Review process validation, equipment qualification, method validation, cleaning validation, and sterility assurance activities. Identify audit observations, classify findings (critical/major/minor), and prepare clear and objective audit reports. Follow up on CAPA implementation and verify effectiveness checks. Provide inspection readiness support for FDA, EMA, MHRA, Health Canada, and other health authority inspections. Collaborate with QA, Regulatory Affairs, Manufacturing, and Supply Chain to ensure a culture of compliance and continuous improvement. Required Qualifications
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Biology, Engineering, or a related field. Minimum 5+ years of experience in GMP auditing within the pharmaceutical and/or medical device industry. Strong knowledge of FDA 21 CFR Parts 210/211 (Drugs), 820 (Devices), Part 11 (Electronic Records), EU GMP Guidelines, ISO 13485, ICH Q-series, and related standards. Demonstrated experience in conducting audits of CMOs, CROs, laboratories, and suppliers. Excellent understanding of quality systems, risk management, and data integrity principles. Strong analytical, problem-solving, and report-writing skills. Ability to work independently and manage multiple audits across global sites. Professional auditor certification (e.g., ASQ CQA, RQAP-GCP, ISO Lead Auditor) is a plus. Additional Skills & Attributes
Strong attention to detail and ability to assess complex processes. Effective communication and presentation skills (verbal & written). Ability to build rapport with auditees and maintain professional objectivity. Critical thinking with a risk-based mindset. Flexibility to travel (domestic and international) up to 25–50% as required. Remote role with travel to client sites as needed to complete audits. Collaborate with cross-functional teams and external partners. Seniority level
Associate Employment type
Part-time Job function
Quality Assurance Industries
Medical Equipment Manufacturing Pharmaceutical Manufacturing Location: Parsippany, NJ
#J-18808-Ljbffr