Quality Auditor - GxP (Pharmacy Compounding/503B)

 

Quality Auditor - GxP (Pharmacy Compounding/503B)

 

What you will be doing:

Execute routine GxP audits (with emphasis on CGMP/503B environments) 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 and drive continuous improvement that protects member and patient safety. Regular travel is required for onsite evaluations.

Key Responsibilities

Responsibility #1 – Plan & Prepare Audits (20%)

• Build audit plans, agendas, and document requests using internal inspection frameworks (e.g., 503B inspection plan); align scope with stakeholders and program goals.

Responsibility #2 – Conduct Onsite GxP Audits (35%)

• Perform facility walkthroughs, process witnessing, and records review across quality systems (e.g., deviations/CAPA, change control, training, equipment/validation, EM/cleanroom controls, sterility assurance).

• Interview personnel and observe practices against FDA CGMP and applicable USP standards.

Responsibility #3 – Author Evaluation Summary Reports (15%)

• Document observations with objective evidence, and issue clear reports with defensible rationale; offer recommendations for compliance or improvement following best practices.

• Finalize evaluation into a standardized summary format and engage with supplier on finalization

Responsibility #4 – Ongoing Quality Reviews (25%)

• Review supplier quarterly quality reports and author a summary of the findings in conjunction with supplier updates, recommendations tracking, and other key information.

Responsibility #5 – Continuous Improvement (10%)

• Maintain current knowledge of CGMP and FDA/USP guidance; help refine internal audit tools and templates

​Required Qualifications

Work Experience:

Years of Applicable Experience - 5 or more years

Education:

High School Diploma or GED (Required)

 

Required Certifications/Licensing

• Preferred:

  • ASQ Certified Quality Auditor (CQA)

  • ASQ Certified Pharmaceutical GMP Professional (CPGP)

  • Board Certification in Sterile Compounding (BCSCP)

  • Auditor Training by ASQ

  • Lean six Sigma Green Belt or Higher

Preferred Qualifications

Skills:

• Expert working knowledge of FDA CGMP (21 CFR Parts 210/211), data integrity (ALCOA+), and USP standards applicable to industry (e.g., USP <71>) applied in audits.

• Proficiency auditing EM programs, aseptic processing, and microbiology controls (e.g., media fills, gowning, viable/non‑viable monitoring, sterility assurance).

• Strong root‑cause analysis and CAPA evaluation; concise technical writing for customer‑facing audit reports.

• Relationship management and consultative communication with suppliers, internal leaders, and member stakeholders

• Project Management: Ability to manage complex projects involving cross-functional teams and deadlines

• Communication: Excellent verbal and written communication skills; ability to communicate and build relationships with suppliers at various levels within the organization.

Experience:

• 3–7+ years in GxP quality, auditing, or regulatory compliance within pharmaceuticals/503B, testing labs, or related suppliers; direct onsite audit experience preferred.

• Demonstrated experience assessing quality systems (deviations/CAPA, change control, complaints, validation, training) and micro/EM programs in sterile environments.

Education:

• Bachelor’s degree in a STEM field (Science, Technology, Engineering, Mathematics), including, but not limited to Pharmacy, Microbiology, Chemistry, Engineering, or equivalent experience.

 

Additional Job Requirements:

• Remain in a stationary position for prolonged periods of time 

• Be adaptive and change priorities quickly; meet deadlines 

• Attention to detail 

• Operate computer programs and software 

• Ability to communicate effectively with audiences in person and in electronic formats.