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

) applied in audits.

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

Strong rootcause analysis and CAPA evaluation; concise technical writing for customerfacing 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 .

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

Working Conditions : Remote

Travel Requirements : Travel 1-20% within the US

Physical Demands : Light : Exerting up to 20 pounds of force frequently, and / or a negligible amount of force constantly to move objects. If the exertion of forces required is greater than that of sedentary work and if the worker remains stationary most of the time, the job is considered light work.

Premier's compensation philosophy is to ensure that compensation is reasonable, equitable, and competitive in order to attract and retain talented and highly skilled employees. Premier's internal salary range for this role is $90,000 - $150,000. Final salary is dependent upon several market factors including, but not limited to, departmental budgets, internal equity, education, unique skills / experience, and geographic location. Premier utilizes a wide-range salary structure to allow base salary flexibility within our ranges.

Employees also receive access to the following 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

Premier at a glance :

Ranked #1 on Charlotte's Healthiest Employers list for 2019, 2020, 2022, and 2023 and 21st Healthiest Employer in America (2023)

Named one of the World's Most Ethical Companies by Ethisphere Institute for the 16th year in a row

Modern Healthcare Best in Business Awards : Consultant - Healthcare Management (2024)

The only company to be recognized by KLAS twice for Overall Healthcare Management Consulting

For a listing of all of our awards, please visit the Awards and Recognition section on our company website.

Employees receive : Perks and discounts

Access to on-site and online exercise classes

Premier is looking for smart, agile individuals like you to help us transform the healthcare industry. Here you will find critical thinkers who have the freedom to make an impact. Colleagues who share your thirst to learn more and do things better. Teammates committed to improving the health of a nation. See why incredible challenges require incredible people.

Premier is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to unlawful discrimination because of their age, race, color, religion, national origin, ancestry, citizenship status, sex, sexual orientation, gender identity, gender expression, marital status, familial status, pregnancy status, genetic information, status as a victim of domestic violence, covered military or protected veteran status (e.g., status as a Vietnam Era veteran, disabled veteran, special disabled veteran, Armed Forces Serviced Medal veteran, recently separated veteran, or other protected veteran) disability, or any other applicable federal, state or local protected class, trait or status or that of persons with whom an applicant associates. We also consider qualified applicants with criminal histories, consistent with applicable federal, state and local law. In addition, as a federal contractor, Premier complies with government regulations, including affirmative action responsibilities, where they apply. EEO / AA / Disabled / Protected Veteran Employer.

Premier also provides reasonable accommodations to qualified individuals with a disability or those who have a sincerely held religious belief. If you need assistance in the application process, please reply to diversity_and_accommodations@premierinc.com or contact Premier Recruiting at 704.816.5200.

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