Quality Assurance Associate
Intertek - San Diego, CA

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Intertek Analytical Services combines expertise with advanced analytical laboratory services to provide added value to clients across a wide range of industries including Upstream Oil & Gas, Refining, Chemical and Materials, Pharmaceutical and Biotechnology.
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 qualitiy assurance procedures.

RESPONSIBILITIES
Represent and interact with multiple departments to provide GLP guidance in an effective manner.
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.
Review validation and project data for compliance to SOPs and Bioanalytical Procedures (BPs).
Determine that no deviations from approved protocols / plans or standard operating procedures were made without prior authorization and documentation.
Assure compliance with GLP regulations and company procedures (SOPs and BPs).
Troubleshoot and take the initiative on any QA-relatead issues with regards to GLP compliance.
Submit to Study Director and / or Study Facility Managment periodic written reports of each study, noting any problems or corrective actions taken.
Assist with developing, revising, and reviewing SOPs. Perform SOP revision training, when necessary.
Assist with performing study phase (in-life) inspections to ensure compliance and integrity of the study.
Assist with maintaining training records of all employees.
Assist with performing facility inspections to ensure laboratory maintains compliance.
Support all other QA functions as required.

Intertek offers a culture where motivated and customer-oriented employees can flourish, experience professional fulfillment, and reach their highest potential. We also offer a generous compensation and benefits package including medical, dental, vision, life insurance, disability, 401(k) with company matching, tuition reimbursement, and a generous paid time off package.
EOE

Intertek - 15 months ago - save job - block
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About this company
114 reviews
Intertek is a nosy nellie when it comes to product safety and international trade. The company, a leading provider of testing and inspection...