QA Project Manager

Eurofins USA PSS Insourcing Solutions•West Point, PA

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 analyzes quality indicators and data to identify potential risks and develop risk-management strategies, and conducts audits including GLP, BA/BE, and VCA audits. It serves as a technical resource for GLP and regulated laboratory issues, contributes to QA procedures, guidance documents, and audit tools, and supports the resolution and escalation of quality issues, root-cause investigations, and CAPAs. The position also provides timely resolution of findings and reporting to appropriate personnel and leadership, shares relevant regulatory citations and information, may participate in compliance-awareness sessions, trains QA colleagues, and provides inspection-management support as needed. Other projects or assignments may be directed by management. This is a full-time position, generally Monday through Friday, 8 a.m. to 5 p.m.; weekend work might be expected. Candidates living within commuting distance of West Point, Pennsylvania are encouraged to apply.

Requirements

BS/BA degree in a scientific concentration.
10 years of 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.

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.
Analyze quality indicators and data to identify potential risks and develop risk-management strategies.
Conduct audits, including GLP, BA/BE, and VCA audits.
Serve as a technical resource for GLP or regulated laboratory-area issues.
Participate in developing QA procedures, guidance documents, and audit tools.
Escalate quality issues promptly and participate in root-cause investigations and CAPAs.
Ensure timely resolution of findings and provide reports to appropriate personnel and leadership.
Stay informed about regulatory citations and other pertinent information and distribute it to personnel.
Participate in compliance-awareness sessions as needed.
Train other QA colleagues.
Provide inspection-management support as needed.
Complete other projects or assignments as directed by management.