Pharmaceutical Quality Associate

Description GENERAL SUMMARY: A member of the Quality Assurance (QA) team for a veterinary pharmaceutical manufacturing company. Responsible for coordinating, preparing and issuing all manufacturing, packaging, and testing documents for scheduled production and for maintaining the Master Batch Records. Responsible for reviewing all in‑process and finished product lot documentation to ensure compliance with cGMP, SOP, and FDA regulations for release of product. Responsible for data entry and trending of all in‑process, finished product, and manufacturing data per product for use in investigations, monthly management reviews, and annual product reviews. Provides recommendations, resolutions, and takes appropriate action to ensure compliance. As required, backs up QA line personnel performing quality checks and documentation review. Primary Responsibilities Determine and select appropriate master documents, test specifications, and worksheets for assembling and preparing complete and accurate production batch records. Calculate and assign expiration dates for each scheduled product. Administer the issuance of all necessary documents for each scheduled product; assure and verify critical information such as lot number and expiration date. Develop appropriate batch records to meet documentation requirements of validation protocols, special studies, and component qualification. Perform thorough review of production batch records, cleaning, laboratory testing documentation, etc., and forward production batches to the QA supervisor for final release ensuring release timelines are met. Work with Operations and Quality personnel to correct identified deficiencies to ensure timely release of batches. Generate Certificates of Analysis and Compliance for each production lot. Generate Minitab charts for in‑process and finished product using Minitab Statistical Software. Review and release incoming raw materials. Track batch release performance metrics and provide them to compliance for inclusion in management review meetings and product reviews. Assist in the review and revision of SOPs, protocols, and special studies required for compliance with batch records. Ensure all batch record and specification sheet maintenance, issuance, revision, and review SOPs remain compliant with FDA expectations and reflect current First Priority practices. Control and maintain the current files for all master batch records, test methods, and specification sheets required for manufacturing, packaging, and testing. Perform API calculations per the batch record requirements. Issue OOS No., NIDR No., QA Hold Notification and maintain electronic log and logbook. Review Brite Stock packets. Assist, as needed, in performing QA specialist tasks on manufacturing lines. Assist in Label Room as necessary. Lead special projects as requested by management. Requirements Qualifications Education And/or Experience Bachelor’s Degree with 0‑2 years’ work experience or High School degree with 4+ years’ experience in pharmaceutical quality with experience in documentation review. Basic knowledge of Microsoft Office (Word, PowerPoint, Excel, Outlook) required. Training Good Manufacturing Practices (GMP) Quality Assurance Procedures Work Environment Office environment Occasional work in light manufacturing environment Working independently with minimal supervision Low to medium noise level Temperature controlled environment Tools And Equipment Microsoft Office Quality Management Systems Program Copy Machine Calculator FLSA: Non-Exempt #J-18808-Ljbffr First Priority, Inc