Job Description
- Job Description:
- Execute routine GxP audits of outsourcing facilities, pharmaceutical testing laboratories, and related suppliers
- Plan and perform onsite evaluations, assess quality systems and data integrity practices
- Produce clear audit reports, partner with suppliers and internal stakeholders to close findings
- Conduct facility walkthroughs, process witnessing, and records review across quality systems
- Document observations with objective evidence in evaluation summary reports
- Review supplier quarterly quality reports and author a summary of findings
- Maintain current knowledge of CGMP and FDA/USP guidance
- Requirements:
- 5 or more years of experience in GxP quality, auditing, or regulatory compliance
- High School Diploma or GED (Required)
- Preferred: ASQ Certified Quality Auditor (CQA)
- Preferred: ASQ Certified Pharmaceutical GMP Professional (CPGP)
- Preferred: Board Certification in Sterile Compounding (BCSCP)
- Preferred: Auditor Training by ASQ
- Preferred: Lean six Sigma Green Belt or Higher
- Expert working knowledge of FDA CGMP (21 CFR Parts 210/211), data integrity (ALCOA+), and USP standards applicable to industry
- Proficiency auditing EM programs, aseptic processing, and microbiology controls
- Strong root-cause analysis and CAPA evaluation
- Experience assessing quality systems (deviations/CAPA, change control, complaints, validation, training) and micro/EM programs in sterile environments
- Benefits:
- Health, dental, vision, life and disability insurance
- 401k retirement program
- Paid time off
- Participation in Premier’s employee incentive plans
- Tuition reimbursement and professional development opportunities
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