Premier

Quality Auditor - GxP (Pharmacy Compounding/503B)

New

Pay$90000.00 - $150000.00 / year
LocationMyrtle Point/Oregon
Employment typeFull-Time
  • Job Description

      Req#: R0008170
      Employer Industry: Pharmaceutical Quality Assurance

      Why consider this job opportunity:
      - Salary up to $150,000
      - Access to health, dental, vision, life, and disability insurance
      - 401k retirement program with employer contributions
      - Paid time off and participation in employee incentive plans
      - Opportunities for tuition reimbursement and professional development
      - Recognized as one of the World’s Most Ethical Companies® and ranked as a top employer for healthy work environments

      What to Expect (Job Responsibilities):
      - Plan and prepare audits, including building audit plans and aligning scope with stakeholders
      - Conduct onsite GxP audits, performing facility walkthroughs, process witnessing, and records reviews
      - Author evaluation summary reports documenting observations and providing compliance recommendations
      - Review supplier quarterly quality reports and summarize findings for continuous quality improvement
      - Maintain current knowledge of CGMP and FDA/USP guidance while refining internal audit tools

      What is Required (Qualifications):
      - Minimum of 5 years of applicable work experience in GxP quality, auditing, or regulatory compliance
      - High School Diploma or GED
      - Demonstrated experience assessing quality systems and micro/EM programs in sterile environments
      - Excellent verbal and written communication skills
      - Ability to manage complex projects involving cross-functional teams

      How to Stand Out (Preferred Qualifications):
      - Bachelor’s degree in a STEM field, such as Pharmacy, Microbiology, Chemistry, or Engineering
      - ASQ Certified Quality Auditor (CQA) or ASQ Certified Pharmaceutical GMP Professional (CPGP)
      - Proficiency in auditing EM programs and aseptic processing
      - Strong root-cause analysis and CAPA evaluation skills
      - Experience working directly in onsite audits within pharmaceuticals/503B testing labs

      #PharmaceuticalQuality #GxPAuditing #CareerOpportunity #CompetitiveSalary #ProfessionalDevelopment

      "We prioritize candidate privacy and champion equal-opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately. We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer."
  • About the company

      Created by hospitals to unite a fragmented system, Premier unites an alliance of 3,750 hospitals and 130,000 other providers to transform healthcare. Our mission is to improve the health of communities. Thousands of Premier members work together each d...

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