QA Specialist-GLP/BIO
On-siteExton, Pennsylvania, United States
Exton, Pennsylvania, United StatesOn-siteFull TimeBachelors DegreeMedium
Full TimeBachelors DegreeMedium
Job Summary
Conduct QA audits of BIO laboratories, functions, ongoing processes, data reviews, technical reports, and study independent facilities. Report quality issues to QA management, Study Directors, and laboratory leaders. Maintain detailed audit notes, reports, and records on Frontage Systems. Review, support, and maintain Standard Operating Procedures. Provide oversight and input to investigations and CAPAs. Support and train staff on GLP regulations and SOPs. Ensure compliance with US FDA, OECD, ICH, and 21 CFR requirements.
Required Qualifications
- Working knowledge of US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidance and publications
- BS/BA in a relevant scientific discipline
- Experience in quality systems and quality assurance processes, development and documentation
Desired Qualifications
- Experience in Bio-Analytical Laboratory
Hiring someone like this?
Get your role in front of qualified candidates on Sorce.