Quality Auditor – GxP, Pharmacy Compounding/503B
Premier Inc.
full-time
Posted on:
Location Type: Remote
Location: United States
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Salary
💰 $90,000 - $150,000 per year
About the role
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GxP auditingregulatory compliancedata integrityroot-cause analysisCAPA evaluationquality systems assessmentmicrobiology controlsaseptic processingLean Six Sigma Green BeltFDA CGMP
Soft Skills
communicationcollaborationreport writinganalytical thinkingattention to detail
Certifications
ASQ Certified Quality Auditor (CQA)ASQ Certified Pharmaceutical GMP Professional (CPGP)Board Certification in Sterile Compounding (BCSCP)Auditor Training by ASQ