Quality Assurance Specialist

About This Opportunity 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 Review and verify raw material documentation (e.g., Certificates of Analysis, Certificates of Compliance, and material specifications) for compliance with internal and regulatory requirements. Perform QA-related entries and reviews in inventory management systems (e.g., SAP or LIMS) related to raw material status changes (quarantine/release/reject). Assist in the documentation and investigation of raw material-related deviations, discrepancies, and OOS/OOT results in coordination with QA and QC teams. Assist with Deviations and CAPAs for the Batch Record/Raw Material group. Open and complete MRB DEVNs for raw material department. Participate in the evaluation of changes related to raw materials (e.g., supplier, specification, or process changes) under the QA change control process. Help track batch records and raw materials. Help create and maintain metrics for batch records and raw materials. Oversee the QA release meeting to ensure releases are on track. Serve as QA contact with Manufacturing and QC for all batch record issues, corrections, prioritizations, and requests. Oversee training of new employees (batch record reviews, raw materials reviews). Release, track, prioritize, and fill requests for raw materials. Attend or lead all raw material meetings, including interaction with other departments such as QC, Milford Supply Chain, Cincinnati Supply Chain, etc. 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 QA Lead Supervisors. Supervise others (as needed). Perform walk-throughs of manufacturing suites (as needed). Maintain knowledge of SAP system for release/rejection of raw materials. Prepare raw material-related documents and files for internal, customer, or regulatory audits; participate in audit backroom as needed. Lead internal audits. Interface with Manufacturing, Purchasing, QC, Warehouse, and Supply Chain to ensure timely and compliant material release and disposition activities. Provide assistance during cGMP compliance inspections of the Milford facility, including retrieving quality documents/records/trend data and any other documentation requested during these inspections. Attend daily QA meetings. Review and approve AA and HVAC Reports (as needed). Required Skills/Abilities The job requires a BS/BA in science or equivalent work experience with 5 years’ experience in either Production or Quality Assurance. Must be able to gown up and enter Manufacturing suites for walk-throughs and MRB labeling. Must have deviation and/or MRB experience. Provide 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. #J-18808-Ljbffr