• Function as the lead auditor both independently and as part of a team to ensure compliance to GxPs, client policies, international guidelines and departmental SOPs
• Proactively identify and analyze quality indicators and data to identify potential risks and create risk management strategies
• Conduct a wide range of audits (such as GLP, BA/BE/VCA)
• Serve as a technical resource to resolve GLP or regulated lab area issues, actively participate in the development of QA procedures, guidance documents and audit tools
• Escalate quality issues in a timely manner to leadership, participate in root cause and CAPAs
• Provide timely resolution of findings and reports to appropriate personnel and leadership
• Stay aware of regulatory citations and other pertinent information to distribute to personnel, may participate in compliance awareness sessions
• Train other QA colleagues
• Provide inspection management support as needed
• Complete other projects or assignments as directed by management
• Minimum Qualifications:BS/BA degree in a scientific concentration10 years of previous QA experience in the pharmaceutical industry, experience in a broad range of auditingAuthorization to work in the United States indefinitely without restriction or sponsorship
• Desired Qualifications:Business acumen, strong understanding of pharmaceutical industryAbility to prioritize and plan out projects, establish detailed action plansIdentify and understand complex problems, analyze and seek out solutionsNetwork and build partnerships across work groups
Position is full-time, Monday-Friday, generally 8 a.m. - 5 p.m., weekend work might be expected. Candidates currently living within a commutable distance of West Point, PA are encouraged to apply.
• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.