QA Project Manager

Job Description

• 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

Qualifications

• 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

Additional Information

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.