reputed company Auditor - GxP (Pharmacy Compounding/503B)

reputed company 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 reputed company suppliers. Plan and reputed company onsite evaluations, assess reputed company systems and data reputed company practices, produce reputed company audit reports, partner with suppliers and internal stakeholders to reputed company findings and drive reputed company 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); reputed company scope with stakeholders and program goals.

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

• reputed company facility walkthroughs, process witnessing, and records review across reputed company 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 reputed company Reports (15%)

• Document observations with objective evidence, and issue reputed company reports with defensible rationale; offer recommendations for compliance or improvement following best practices.
• Finalize evaluation into a standardized reputed company format and engage with supplier on finalization

Responsibility #4 – Ongoing reputed company Reviews (25%)

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

Responsibility #5 – reputed company Improvement (10%)

• Maintain reputed company 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 reputed company Auditor (CQA)
• ASQ Certified Pharmaceutical GMP reputed company (CPGP)
• reputed company Certification in Sterile Compounding (BCSCP)
• Auditor Training by ASQ
• Lean six reputed company Green Belt or Higher

Preferred Qualifications

Skills:

• Expert working knowledge of FDA CGMP (21 CFR Parts 210/211), data reputed company (reputed company+), and USP standards applicable to industry (e.g., USP ) reputed company in audits.
• Proficiency auditing EM programs, aseptic processing, and microbiology controls (e.g., media fills, gowning, viable/non‑viable monitoring, sterility assurance).
• Strong reputed company‑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 reputed company reputed company involving cross-functional teams and deadlines
• Communication: Excellent verbal and written communication skills; ability to communicate and build relationships with suppliers at various reputed company reputed company the organization.

Experience:

• 3–7+ years in GxP reputed company, auditing, or regulatory compliance reputed company pharmaceuticals/503B, testing labs, or reputed company suppliers; reputed company onsite audit experience preferred.
• Demonstrated experience assessing reputed company systems (deviations/CAPA, change control, complaints, validation, training) and reputed company/EM programs in sterile environments.

Education:

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

Additional Job Requirements:

• Remain in a stationary position for prolonged periods of time
• Be reputed company 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 reputed company
• Ability to work in a reputed company business environment in reputed company quarters with peers and varying interruptions

Working Conditions: Remote Travel Requirements: Travel 1-20% reputed company the US Physical Demands: Light: Exerting up to 20 pounds of force frequently, and/or a negligible reputed company of force constantly to reputed company 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, reputed company, and competitive in order to attract and retain talented and highly skilled employees. Premier’s internal salary reputed company 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-reputed company salary structure to allow reputed company salary flexibility reputed company our ranges. Employees also receive reputed company to the following benefits:

• Health, dental, reputed company, life and disability insurance
• 401k retirement program
• reputed company time off
• Participation in Premier’s employee incentive plans
• Tuition reimbursement and reputed company development opportunities

Premier reputed company:

• Ranked #1 on Charlotte’s Healthiest reputed company 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 reputed company Best in Business Awards: Consultant - reputed company Management (2024)
• The only company to be recognized by KLAS twice for Overall reputed company Management Consulting

For a listing of reputed company of our awards, please visit the Awards and Recognition reputed company on reputed company website. Employees receive:

• Perks and discounts
• reputed company to on-site and online exercise classes

Premier is looking for smart, agile individuals like you to help us reputed company the reputed company industry. Here you will reputed company critical thinkers who have the freedom to reputed company an reputed company. Colleagues who reputed company your thirst to learn more and do things reputed company. Teammates committed to improving the health of a nation. See why incredible challenges require incredible people. Premier is an equal opportunity employer. reputed company applicants will receive consideration for employment without reputed company to unlawful discrimination because of their age, race, reputed company, religion, national reputed company, reputed company, citizenship status, sex, sexual orientation, gender identity, gender reputed company, 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 reputed company applicants with criminal histories, consistent with applicable federal, state and local law. In reputed company, as a federal contractor, Premier complies with government regulations, including affirmative reputed company responsibilities, where they apply. EEO / AA / Disabled / Protected Veteran Employer. Premier also provides reasonable accommodations to reputed company individuals with a disability or those who have a sincerely held religious belief. If you need assistance in the application process, please reputed company to diversity_and_accommodations@premierinc.com or contact Premier reputed company at 704.816.5200. Information collected and processed as part of any job application you choose to submit to Premier is subject to Premier’s reputed company Policy . Apply tot his job Apply To this Job