Quality Assurance Specialist III Raw Material/Batch Record Review

Quality Assurance Specialist III Raw Material/Batch Record Review

As a Quality Assurance Specialist III, you will be responsible for being a lead QA representative for Raw Materials and Batch Records functions. Key responsibilities include reviewing and verifying raw material documentation for compliance with internal and regulatory requirements, performing QA-related entries and reviews in inventory management systems, assisting in the documentation and investigation of raw material-related deviations, discrepancies, and OOS/OOT results, and participating in the evaluation of changes related to raw materials under the QA change control process. You will also help track batch records and raw materials, create and maintain metrics for batch records and raw materials, oversee the QA release meeting, and provide QA contact with Manufacturing and QC for all batch record issues, corrections, prioritizations, and requests. Additionally, you will oversee training of new employees, releases, tracks, prioritizes, and fills requests for raw materials, attend or lead all raw material meetings, ensure MRBs for raw materials are initiated and completed in a timely manner, support and review QA raw material/batch record CAPAs and Deviations, support the QA Lead Supervisors, supervise others as needed, perform walk-through of manufacturing suites as needed, and prepare raw material-related documents and files for internal, customer, or regulatory audits. Required skills include a BS/BA in science or equivalent work experience with 5 years' experience in either Production or Quality Assurance, the ability to gown up and enter Manufacturing suites for walk-throughs and MRB labeling, deviation and/or MRB experience, and sound decision-making and guidance on all aspects of batch record review and raw material release. The annualized salary range for this role is $73,700.00 - $89,177.00.