QA Project Manager

Eurofins • Upper Gwynedd Township, PA

6d

About The Position

The QA Project Manager functions as a lead auditor, independently and as part of a team, to ensure compliance with GxPs, client policies, international guidelines, and departmental SOPs. The role identifies and analyzes quality indicators and data to detect potential risks and develop risk-management strategies. It conducts audits such as GLP, BA/BE, and VCA; serves as a technical resource for GLP and regulated laboratory issues; and contributes to the development of QA procedures, guidance documents, and audit tools. The position also supports issue escalation, root-cause analysis, CAPAs, inspection management, and the training of QA colleagues. The role is full-time, generally Monday through Friday from 8 a.m. to 5 p.m.; weekend work might be expected. Candidates within commuting distance of West Point, Pennsylvania are encouraged to apply.

Requirements

• BS/BA degree in a scientific concentration.
• 10 years of previous QA experience in the pharmaceutical industry, including experience in a broad range of auditing.
• Authorization to work in the United States indefinitely without restriction or sponsorship.

Nice To Haves

• Business acumen and a strong understanding of the pharmaceutical industry.
• Ability to prioritize and plan projects and establish detailed action plans.
• Ability to identify and understand complex problems, analyze them, and seek solutions.
• Ability to network and build partnerships across work groups.

Responsibilities

• Function as lead auditor independently and as part of a team to ensure compliance with GxPs, client policies, international guidelines, and departmental SOPs.
• Identify and analyze quality indicators and data to detect potential risks and create risk-management strategies.
• Conduct a wide range of audits, including GLP, BA/BE, and VCA audits.
• Serve as a technical resource to resolve GLP or regulated laboratory-area issues.
• Participate in developing QA procedures, guidance documents, and audit tools.
• Escalate quality issues to leadership in a timely manner and participate in root-cause analysis and CAPAs.
• Provide timely resolution of findings and reports to appropriate personnel and leadership.
• Stay aware of regulatory citations and other pertinent information and distribute it 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.

Benefits

• Comprehensive medical coverage.
• Dental options.
• Vision options.
• Life insurance.
• Disability insurance.
• 401(k) with company match.
• Paid vacation.
• Paid holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior