GMP Compliance Auditor

Efficient Auditing; Chicago (IL); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Professional development opportunities

Supportive team culture

High-impact projects

Job summary

A regulatory compliance firm is seeking a GMP Compliance Auditor in Chicago, IL, to evaluate and ensure adherence to Good Manufacturing Practices across various life-science sectors. The ideal candidate will possess 3-7 years of extensive auditing experience and a relevant degree. Responsibilities include conducting audits, assessing regulatory compliance, and providing CAPA guidance. Join our collaborative team to work on impactful projects enhancing product quality and patient safety.

Qualifications

• 3–7 years of experience in GMP auditing, compliance, or quality assurance.
• Strong understanding of pharmaceutical manufacturing requirements and quality systems.
• Excellent report writing and communication skills.

Responsibilities

• Conduct GMP audits for clients including facility and documentation evaluations.
• Assess compliance with FDA, EMA, WHO regulations.
• Identify non-conformities and improvement opportunities.

Skills

GMP auditing

Regulatory compliance

Analytical skills

Report writing

Communication skills

Education

Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Life Sciences, Engineering

Job description

We are looking for a highly knowledgeable GMP Compliance Auditor to join our growing team. This role focuses on evaluating, improving, and ensuring compliance with global Good Manufacturing Practices (GMP) across pharmaceutical, biotech, medical device, and life‑science organizations. The ideal candidate will have strong experience conducting audits, preparing organizations for regulatory inspections, and guiding clients through corrective and preventive actions (CAPA).

Key Responsibilities

• Conduct GMP audits for clients, including facility, documentation, and process evaluations.
• Assess compliance with FDA, EMA, WHO, PIC/S, MHRA, and other global regulatory bodies.
• Identify non‑conformities, risks, and improvement opportunities during audits.
• Prepare detailed audit reports, CAPA recommendations, and follow‑up evaluations.
• Support clients in building robust GMP systems and maintaining inspection readiness.
• Assist in preparing documentation for Pre‑Approval Inspections (PAI) and GMP licensing audits.
• Provide consultation on quality controls, manufacturing processes, batch records, and qualification/validation requirements.
• Develop and deliver GMP training sessions for client staff.
• Collaborate with cross‑functional teams to בראש implement compliance improvements and achieve certification or regulatory approval.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Life Sciences, Engineering, or a related field.
• 3–7 years of experience in GMP auditing, compliance, or quality assurance.
• Strong understanding of pharmaceutical manufacturing requirements and quality systems.
• Demonstrated experience with internal, external, or supplier audits.
• Solid knowledge of ISO 9001, ISO 13485, GMP, GDP, and GLP standards.
• Excellent report‑writing, analytical, and communication skills.
• Ability to manage multiple audits and client engagements independently.

Preferred Skills

• Certification such as GMP Auditor, ISO Lead Auditor, or Certified Quality Auditor (CQA).
• Experience with sterile manufacturing, biologics, or API production.
• Understanding of risk management methodologies such as FMEA or HACCP.
• Familiarity with digital QMS tools or audit management systems.

Why Join Us?

• Work closely with global clients in regulated industries.
• Participate in high‑impact projects that strengthen patient safety and product quality.
• Grow your expertise in GMP auditing, regulatory compliance, and ISO standards.
• Supportive team culture with opportunities for professional development.