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Job Description & Requirements
QUALITY ANALYST / BATCH RECORDS REVIEWER: A Bachelor's Degree in Medical Technology or equivalent scientific field is preferred and/or a minimum of 3 years professional experience in an FDA-regulated environment or equivalent industrial experience is required. A good understanding and application of scientific principles and methodologies with regard to medical technology, and life science is required for this position. Thorough knowledge of FDA, QSR, ISO and GMP requirements for pharmaceuticals and medical devices is required. Additional skills required for this position include the following: the ability to schedule work load to meet department and team goals with minimum supervision, good organizational and time management skills to meet multiple and changing priorities, good written and verbal communication skills, the ability to interact with various department personnel. The ideal candidate for this position will also be required to possess the ability to detect and resolve errors and discrepancies, the ability to recommend tactical solutions to management for review and implementation and the ability to assess conditions that could potentially impact safety and efficacy of products. Strict attention to detail and the ability to focus attention and work in a fast paced environment are key to success in this position.
QUALITY ANALYST/BATCH RECORDS REVIEWER: 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).
PLEASE NOTE THIS POSITION IS FOR A QUALITY ANALYST / BATCH RECORDS REVIEWER PER THE JOB DESCRIPTION IN THIS REQUISITION. PLEASE RECRUIT TO THIS JOB DESCRIPTION. THANKS.
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