Sr. Quality Assurance Associate

Third Party Quality Senior Associate Job Description The Third Party Quality Senior Associate will be responsible for the review and disposition of batch record documentation for Alora distributed products manufactured by external third parties in accordance with site SOP and regulatory guidance. The position will also perform the quality review of related cGMP documentation for Alora distributed products, including annual product reviews, and will assist with the coordination of global change controls. Key Responsibilities/Essential Functions Critically review and disposition batch record documentation for products manufactured by external third parties. Perform the quality review of related cGMP documentation generated at third parties including, but not limited to deviations, out-of-specification investigations, change controls, process validation protocols/reports, and master batch records. Assign and/or approve lot numbers and expiration dates for products transferred to packaging facilities, as required. Review annual product reviews generated by third party vendors. Collect, review, and report product data needed to supplement third-party vendor annual product reviews. Collect and review the changes to USP and initiate any associated change controls related to those changes. Assist with the execution of a corporate USP change management system. Monitor and assist with the implementation of new corporate policies. Collect and review the changes to regulatory policies and assist in the implementation of these policies. Review and approve product labeling. Escalate issues to Quality Management, as appropriate, including, but not limited to, product quality, safety, or efficacy concerns identified in annual product reviews and critical issues identified as part of batch record review and related records. Track closure of assigned Third Party Quality records. Monitor due dates for submission of annual product reviews and perform follow‑up activities. Assist with the generation of quality system metrics and trending reports. Assist with the performance of high-risk or global risk assessment impacting Alora manufactured and/or distributed products. Assist with the development and maintenance of procedures that define the cGMP activities within the areas of responsibility. Provide training and guidance to more junior Associates within the Third Party Quality team. Champion quality improvement processes within the areas of responsibility to ensure adherence to cGMPs and foster continuous improvement. Support a culture of quality and continuous improvement throughout the organization. Perform additional duties and responsibilities as assigned by Quality Management. Basic Qualifications A Bachelor's degree preferred and/or 4 years of related work experience. Minimum of 2 years of quality experience in FDA regulated industries (pharmaceutical or biotech industries, preferred). Thorough knowledge of FDA Quality System requirements. Other Requirements Ability to work independently when guided by documented procedures. Able to work effectively as part of a team. Excellent attention to detail. Ability to deliver within established timelines. Fluency in English and excellent comprehension. Strong oral and written communication skills. Proficient with Microsoft office applications. #J-18808-Ljbffr