Our client, a leading biotechnology company, is seeking a Senior Quality Assurance Associate to join their team in San Diego, CA.
The Senior Quality Assurance Associate is expected to have a complete understanding of FDA regulations, as well as basic laboratory quality assurance procedures.
1. Represent the Quality Assurance Unit and interact with multiple departments to provide guidance in an effective manner. 2. Become intimately familiar with company Standard Operating Procedures SOPs , guidelines, and other appropriate regulations and guidelines. Also be familiar with any sponsor SOPs that may apply to studies. 3. Review validation, sample analysis, and associated data, and reports for compliance to regulations and guidelines, the study protocol/plan, SOPs, and Bioanalytical Procedures BPs . 4. Determine that deviations from approved study protocols/plans or SOPs and BPs were made with authorization and documentation. 5. Assure compliance with regulations and guidelines and company procedures SOPs and BPs . 6. Submit to the Study Director and the Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken. 7. Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary. 8. Take the initiative on any QA-related issues with regards to compliance. 9. Periodically review training records of employees. 10. If necessary, interact with the Sponsor QA team during visits to the laboratory as well as prepare written correspondence regarding QA audits and compliance audit findings. 11. Responsible for performing periodic facility inspections to ensure laboratory maintains compliance 12. Responsible for performing study phase in-process inspections to ensure compliance and integrity of the study. 13. Responsible for maintaining the Master Schedule. 14. Support of other QA functions as needed. Possibly supervise another position.
QUALIFICATIONS: Bachelor s degree BA or BS required 5+ years of relevant experience in QA, QC, Regulatory Affairs, or within GXP GCP, GLP, GMP environment.
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Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions. Kelly ® offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis. Serving clients around the globe, Kelly provides employment to more than 560,000 employees annually. Revenue in 2012 was $5.5 billion. Visit kellyservices.com and download The Talent Project , a free iPad ® app by Kelly Services.
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