Premier Inc. · 8 hours ago
Quality Auditor - GxP (Pharmacy Compounding/503B)
United States
Full-time
Onsite
Senior Level
$90K/yr - $150K/yr
5+ years expPremier Inc. is a leading company in the healthcare industry, seeking a Quality Auditor to execute routine GxP audits and assess quality systems for outsourcing facilities and pharmaceutical testing laboratories. The role involves planning and performing onsite evaluations, producing clear audit reports, and partnering with suppliers to drive continuous improvement in quality practices.
Health CareHospitalMedical
Responsibilities
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
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
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
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
Continuous Improvement (10%)
Maintain current knowledge of CGMP and FDA/USP guidance; help refine internal audit tools and templates
Qualification
Required
5 or more years of applicable experience
High School Diploma or GED (Required)
Expert working knowledge of FDA CGMP (21 CFR Parts 210/211), data integrity (ALCOA+), and USP standards applicable to industry (e.g., USP ) 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
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
Day-to-day contact with others (co-workers and/or the public)
Making independent decisions
Ability to work in a collaborative business environment in close quarters with peers and varying interruptions
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
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
Bachelor's degree in a STEM field (Science, Technology, Engineering, Mathematics), including, but not limited to Pharmacy, Microbiology, Chemistry, Engineering, or equivalent experience
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
Perks and discounts
Access to on-site and online exercise classes
Company
Premier Inc.
Premier, Inc. is a leading technology-driven healthcare improvement company, providing solutions to two-thirds of all healthcare providers in the U.S.
1001-5000 employees
H1B Sponsorship
Premier Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (20)
2024 (10)
2023 (25)
2022 (9)
Funding
Current Stage
Public CompanyTotal Funding
unknown2025-09-22Acquired
2013-10-10IPO
Leadership Team
Gregory Montano
Vice President/Senior Vice President, Technology and Financial Operations
Bruce Radcliff
President of Supply Chain Services
Recent News
2025-11-25
Morningstar.com
2025-11-22
Company data provided by crunchbase