About the role
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.