Quality Auditor – GxP, Pharmacy Compounding/503B

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 Apply tot his job Apply To this Job