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. • Oversees the QA release meeting to ensure releases on track. • QA contact with Manufacturing and QC for all batch record issues, corrections, prioritizations, and requests. • Oversees training of new employees (batch record reviews, raw materials reviews) • Releases, tracks, prioritizes, and fills 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. • Responsible for ensuring MRBs for raw materials are initiated and completed in a timely manner. • Supports and reviews QA raw material/batch record CAPAs and Deviations. • Supports the QA Lead Supervisors. • Supervise others (as needed). • Perform walk-through of manufacturing suites (as needed). • Responsible for 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. This includes the retrieving of quality documents/records/trend data and any other documentation requested during these inspections. • Attend daily QA meetings. • Review and approved 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.