Premier
Quality Auditor - GxP (Pharmacy Compounding/503B)
Premier, Myrtle Point, Oregon, United States, 97458
Why consider this job opportunity
Salary up to $150,000
Access to health, dental, vision, life, and disability insurance
401k retirement program with company contributions
Paid time off and tuition reimbursement for professional development
Recognition as one of the World’s Most Ethical Companies and top employer in health and wellness
Opportunity to work remote with minimal travel requirements
What to Expect (Job Responsibilities)
Plan and prepare audit plans, agendas, and document requests using internal inspection frameworks
Conduct onsite GxP audits, including facility walkthroughs and records review
Author evaluation summary reports with observations and recommendations for compliance
Perform ongoing quality reviews of supplier quarterly quality reports
Maintain current knowledge of CGMP and FDA/USP guidance to refine internal audit tools
What is Required (Qualifications)
Minimum of 5 years of applicable experience in GxP quality, auditing, or regulatory compliance
High School Diploma or GED required
Expertise in FDA CGMP and USP standards applicable to the industry
Strong technical writing skills for customer-facing audit reportsAbility to communicate effectively with various stakeholders
How to Stand Out (Preferred Qualifications)
Bachelor’s degree in a STEM field (Science, Technology, Engineering, Mathematics)
ASQ Certified Quality Auditor (CQA) or ASQ Certified Pharmaceutical GMP Professional (CPGP)
Experience auditing EM programs and aseptic processing controls
Strong project management skills involving cross-functional teams
3–7+ years of direct onsite audit experience in pharmaceuticals or testing labs
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.
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Salary up to $150,000
Access to health, dental, vision, life, and disability insurance
401k retirement program with company contributions
Paid time off and tuition reimbursement for professional development
Recognition as one of the World’s Most Ethical Companies and top employer in health and wellness
Opportunity to work remote with minimal travel requirements
What to Expect (Job Responsibilities)
Plan and prepare audit plans, agendas, and document requests using internal inspection frameworks
Conduct onsite GxP audits, including facility walkthroughs and records review
Author evaluation summary reports with observations and recommendations for compliance
Perform ongoing quality reviews of supplier quarterly quality reports
Maintain current knowledge of CGMP and FDA/USP guidance to refine internal audit tools
What is Required (Qualifications)
Minimum of 5 years of applicable experience in GxP quality, auditing, or regulatory compliance
High School Diploma or GED required
Expertise in FDA CGMP and USP standards applicable to the industry
Strong technical writing skills for customer-facing audit reportsAbility to communicate effectively with various stakeholders
How to Stand Out (Preferred Qualifications)
Bachelor’s degree in a STEM field (Science, Technology, Engineering, Mathematics)
ASQ Certified Quality Auditor (CQA) or ASQ Certified Pharmaceutical GMP Professional (CPGP)
Experience auditing EM programs and aseptic processing controls
Strong project management skills involving cross-functional teams
3–7+ years of direct onsite audit experience in pharmaceuticals or testing labs
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.
#J-18808-Ljbffr