QA Project Manager

• 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.