Quality Assurance Technician

The Quality Assurance Technician is responsible for review and release of manufacturing Batch records, ensuring compliance within batch documentation. The QA Technician provides support to the Production and Quality Control teams, identifies the need for initiating and conducting investigations and reviews the complete batch documentation (i.e. production orders, protocols, Production and Quality Control testing results, etc.) as required by established quality systems. The QA Technician has to follow Quality specifications, work instructions, as well as actions that support teamwork, safety, efficiency and cGMP adherence. Primary Duties and Responsibilities: Accurate and timely review and release of manufacturing batch records and other pertinent documents in accordance with the company policies, standards, procedures and cGMPs. Review executed batch records for documentation completeness and accuracy. Adhere to specifications, work instructions and regulatory requirements while reviewing batch documentation. Prepare Certificate of Conformity (COC), Certificate of Analysis (COA), COC/COA templates Perform final disposition of components. Periodic review of Block stock inventory and component consumption. Maintain and archive batch documentation and retains. Conduct and/or review nonconformance investigation reports. Support sorting protocols as needed. Support Supplier Corrective Actions as needed. Initiate changes to Quality documents in compliance with ISO and cGMP requirements. Perform other duties and projects as assigned. The All Required Qualifications High School Diploma required. At least one-year experience in Quality Assurance or Quality Control, preferably in a high-volume manufacturing environment. ISO experience a plus. Skills/Abilities: Detail oriented and rigorous. Strong communication and interpersonal skills. Strong analytical skills; strong proficiency in Math. · Proficient computer skills utilizing SAP and MS Office · Independent, self-motivated,

Created: 2024-10-19