Sr. QC Quality Engineer

Job description

MAIN JOB RESPONSIBILITIES / COMPETENCIES: 1. Coordinate quality engineering activities to achieve business objectives. 2. Provide guidance and leadership on development /review of validation policies, master plans and schedules, and protocols and quality engineering issues. Act as an effective leader or team member in supporting quality disciplines, decisions, and practices 3. Support site engineering functions in process quality and testing improvement activities. Responsible for various analytical activities related to commercial stability program management of products. Review analytical data associated to these stability studies. Generate protocol and reports. 4. Coordinate GMP activities and ensuring batches are tested and released to meet project timelines for commercial needs. 5. Develop timelines, identify critical analytical issues, lead problem solving of technical issues, as well as investigate and resolve any out of specification results 6. Provide technical expertise to the risk documentation process. 7. Provide guidance and leadership on investigations involving manufacturing nonconformance’s, product or component failures, customer complaints, or product returns by l...