Our client, a growing biotechnology company, is seeking Quality Associate or Sr. Quality Associate to join their team in San Diego, CA.
The Quality Assurance Associate is expected to have a complete understanding of FDA, OECD, and MHLW Good Laboratory Practices GLP , as well as basic laboratory quality assurance procedures.
RESPONSIBILITIES: 1. Represent and interact with multiple departments to provide GLP guidance in an effective manner. 2. Become intimately familiar with company Standard Operating Procedures SOPs , FDA, OECD, and MLHW regulations, and other appropriate guidelines and regulations. Also be familiar with any sponsor SOPs that may apply to studies. 3. Review validation and project data for compliance to SOPs and Bioanalytical Procedures BPs . 4. Determine that no deviations from approved protocols/plans or standard operating procedures were made without prior authorization and documentation. 5. Assure compliance with GLP regulations and company procedures SOPs and BPs . 6. Troubleshoot and take the initiative on any QA-related issues with regards to GLP compliance. 7. Submit to Study Director and/or Study Facility Management periodic written reports of each study, noting any problems or corrective actions taken. 8. Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary. 9. Assist with performing study phase in-process inspections to ensure compliance and integrity of the study. 10. Assist with maintaining training records of all employees. 11. Assist with performing facility inspections to ensure laboratory maintains compliance. 12. Support all other QA functions as required.
QUALIFICATIONS: Bachelor s degree BA or BS required 2+ years of relevant experience in QA, QC, or within GXP GCP, GLP, GMP environment
About Kelly Services ®
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.
Our science specialty places professionals to a broad spectrum of industries, including biotechnology, chemical, clinical research, consumer products, biotechnology, consumer products, environmental, food sciences, pharmaceutical, and petrochemical fields.
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Kelly Services, Inc. (Kelly) is a global temporary staffing provider operating in 36 countries and territories throughout the world. The...