The Quality Assurance Engineer is a hands-on individual contributor within the Quality Assurance organization at Recipharm Advanced Bio’s Watertown site. Reporting To: Senior Director, Quality & Regulatory (Watertown Site Quality Head) Key Responsibilities Quality Assurance & Quality Systems CAPA Management Own the site CAPA program end-to-end, including governance, prioritization, follow-up, escalation, and on-time closure Host CAPA Review Board meetings to review CAPA status, progress, and timelines Lead cross-functional CAPA activities, including scheduling meetings, ensuring appropriate root cause analysis, driving on-time closure, maintaining high-quality records, and supporting audit readiness Facilitate product and process CAPA investigations through corrective action implementation and effectiveness monitoring Analyze quality data to identify existing and potential non-conformances Generate Quality KPIs and support continuous improvement initiatives Change Control Management Own the site Change Control program, ensuring compliant execution, effective implementation, and on-time closure Host Change Control Review Board meetings to review change status and implementation progress Manage change requests to ensure changes are documented, reviewed, approved, and implemented in a controlled manner Track change progress and coordinate with cross-functional teams to ensure timely communication and implementation Provide guidance on proper use of the change control process Deviations and Investigations Support deviation investigations and related documentation Provide QA guidance on documentation standards and Quality System requirements Ensure compliance with site procedures, corporate quality standards, and cGMP requirements Drive timely closure of quality records while maintaining inspection-ready documentation Support additional quality projects as needed Documentation & Technical Review Review and approve protocols and reports related to technical transfer, QC investigations, and manufacturing or p...
