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 Now
Apply Now
• 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 Now
Apply Now