Please note that this is a 1 year contract position.
The Quality Analyst / Batch Records Reviewer is responsible for the review and approval of drug and device history records, this includes: verification of technical accuracy, compliance to specifications/requirements, Quality System Regulations and GMPs and compliance with Ortho Clinical Diagnostics processes and procedures. Additionally, the Quality Analyst assures that products meet all the criteria prior to release to CBER/TUV and/or to customers and recommends final dispositions of product and performs product release in the Inventory system. This position identifies and follows up with Operations, Quality Engineering and QA on product quality/batch release discrepancies and determines and recommends any corrective action required. The Quality Analyst prepares and verifies the accuracy of Certificates of Analysis and CBER protocols, measures and analyzes quality and process metrics for trending and quality and productivity reviews, reports unusual trends to department and operations management, identifies areas of improvements, proposes resolution to problems and participates/leads investigation/improvement projects, participates and contributes in intra-department project teams and reviews and revises master device history records, manufacturing batch records, standard operating procedures and process documents as needed. This position also participates in training for team members or external associates (Manufacturing and QA).
For consideration, please reference job number 2535
San Francisco, CAContact