- 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 concentration
- 10 years of previous QA experience in the pharmaceutical industry, experience in a broad range of auditing
- Authorization to work in the United States indefinitely without restriction or sponsorship
- Desired Qualifications:
- Business acumen, strong understanding of pharmaceutical industry
- Ability to prioritize and plan out projects, establish detailed action plans
- Identify and understand complex problems, analyze and seek out solutions
- Network 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.