Senior Quality Specialist
On-site · Lancaster, Pennsylvania, United States
Job Summary
Audits are central to this role: serve as an audit host/escort, answer questions about laboratory and quality systems, document audit scope and items needing attention, communicate audit issues to senior management, provide formal written responses to client audit reports, and ensure timely follow-up. The role requires applying GMP/GLP, staying current with procedures, and training new employees while supporting client audits to verify facility, instrumentation, and regulatory compliance. The position emphasizes data quality, regulatory compliance, and successful audit outcomes in a global lab services environment.
Required Qualifications
- Bachelor's degree in a science-related field or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
- Minimum of three years of Pharmaceutical industry experience with knowledge of regulatory requirements
- Experience with cGMP and/or FDA regulated environments
- Authorization to work in the United States indefinitely without restriction or sponsorship
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