GLP/Bio Quality Assurance Specialist
Exton, PA (Corporate)
Implement, maintain and enhance quality procedures and systems to ensure compliance with US FDA, OECD, and ICH regulatory requirements including 21 CFR Part 58, 21 CFR Part 11, 21 CFR Part 320, and other relevant guidances and publications. One of our groups also works to 40 CFR part 160.
- Conduct QA audits of BIO laboratories and functions including but not limited to: ongoing process, data review audits, technical report, and study independent facility / process.
- Provide input to method, equipment, computer validation programs.
- Assist with oversight of Master Schedule.
- Maintain appropriately detailed notes, audit reports, and records
- Provide input to documentation and data storage systems.
- Ensure that requirements and documentation for all regulated systems are kept current according to changing guidelines and industry standards.
- Provide Regulatory training to staff as necessary.
- Effectively report quality issues to supervisor, Study Director, and management, as appropriate.
- Provide oversight and input to investigations and CAPA, as appropriate
- Conduct outside vendor audits as may be required, including laboratories and services for subcontracting and/or supporting services, and follow-through on any quality issues.
- Review and maintain Standard Operating Procedures (SOP).
- Assist with client audits and regulatory inspections.