What are the responsibilities and job description for the GMP Auditor - testing laboratories - (Pharma/Biotech industry exp is required) - (only on W2) position at LS Solutions?
Job Title: GMP Auditor
Location: Cranbury, NJ (On-Site)
4 months contract (20 hours a week)
GMP Auditor
JOB DESCRIPTION
We are seeking a highly experienced GMP Auditor to support audit preparation and execution for a testing laboratory located in Cranbury, NJ. The ideal candidate will bring deep familiarity with FDA regulations and strong auditing skills focused on 21 CFR Part 210/211 and ICH Q7 Guidelines. This part-time consulting role will require planning and executing the audit in December, writing the audit report, and providing debrief support.
The Role:
· Lead audit preparation activities for a GMP testing laboratory inspection.
· Conduct a comprehensive on-site audit on December 3–4, 2025, evaluating compliance with applicable regulatory standards.
· Draft and finalize detailed audit reports, documenting observations and recommendations.
· Participate in audit debriefs and assist in follow-up communications as needed.
Required Skillset
· 5 years of hands-on experience performing GMP audits.
· Strong knowledge of 21 CFR Part 210/211 and ICH Q7 guidelines.
· Proven ability to write clear, detailed audit reports.
· Availability to support audit preparation prior to December and complete documentation and debrief activities post-audit.
· Prior experience auditing testing laboratories is a plus.
