Quality Assurance Manager

Department: Quality
Reports to: Director of Quality Systems

The Quality Assurance Manager is responsible for all aspects of the company’s Quality Assurance program including acceptance and release of raw materials, review and approval of all batch documentation and disposition of finished product, Quality oversight of manufacturing operations, and administration of the Quality Systems programs and procedures. The position works in a team based environment with Manufacturing, Packaging, Materials, Engineering, and Research & Development to insure company quality, production, and development goals are met.

• Maintain company compliance with external specifications, standards, & regulations by evaluation of current procedures and practices • Evaluate and implement protocols/methods to inspect and test in process raw materials and finished products • Responsible for the hiring, training, development and evaluation of QA personnel • Oversee and participate in an internal training program to include documentation and evaluation of training effectiveness • Oversee and participate in batch record review and coordination of intermediate and finished product releases • Oversee complaint / returned product programs including tracking and corrective actions • Prepare and deliver periodic reporting on quality performance in accordance with company policy and external regulatory requirements • Perform statistical analysis to analyze trends and improve process control • Oversee the implementation of corrective actions and routine change controls • Coordinate closely with Manufacturing, Quality Control, Engineering and Facilities to meet customer requirements • Responsible for Document Control processes and procedures and storage• Oversee supplier quality program and implement systems to measure and track supplier quality • Develop metrics, tracks performance, participate in audits and report results • Responsible for calibration program to include timely calibration of instrumentation, investigation and resolution of out of tolerance results. • Oversee revalidation program and assures adherence to validation master plans. Ensure process, equipment, & methods validations are written in accordance with industry regulations and assesses compliance upon execution • Perform GAP analyses of in-house practices versus relevant regulations, standards and industry practices • Develop, plan and implement corrective actions to ensure continued compliance • Conduct periodic internal audits and oversees internal audit program, recommend corrective action and work with appropriate department to implement required corrective action • Perform other related duties as assigned

The position requires a Bachelors Degree in the life sciences, Masters degree preferred. A minimum of 10 years experience within Quality Assurance with a demonstrated knowedge of GMP is required. Experience working in a high volume manufacturing opertion is preferred. Demonstrated knowledge of regulated industries including experience with FDA, ISO 13485:2003, cGMPs, QSRs, MDD is required. Previous supervisory experience of 3 -5 years is required. The ability to handle multiple priorities and to direct the workforce to execute results is required. Project Management skills preferred.