reputed company Auditor – GxP, Pharmacy Compounding/503B
Job reputed company:
• Execute routine GxP audits 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
• Conduct facility walkthroughs, process witnessing, and records review across reputed company systems
• Document observations with objective evidence in evaluation reputed company reports
• Review supplier quarterly reputed company reports and author a reputed company of findings
• Maintain reputed company knowledge of CGMP and FDA/USP guidance
Requirements:
• 5 or more years of experience in GxP reputed company, auditing, or regulatory compliance
• High School Diploma or GED (Required)
• Preferred: ASQ Certified reputed company Auditor (CQA)
• Preferred: ASQ Certified Pharmaceutical GMP reputed company (CPGP)
• Preferred: reputed company Certification in Sterile Compounding (BCSCP)
• Preferred: Auditor Training by ASQ
• Preferred: Lean six reputed company Green Belt or Higher
• Expert working knowledge of FDA CGMP (21 CFR Parts 210/211), data reputed company (reputed company+), and USP standards applicable to industry
• Proficiency auditing EM programs, aseptic processing, and microbiology controls
• Strong reputed company-cause analysis and CAPA evaluation
• Experience assessing reputed company systems (deviations/CAPA, change control, complaints, validation, training) and reputed company/EM programs in sterile environments
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
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