Quality Assurance Technician

The Quality Assurance Technician is located at and supports the Sirtex Manufacturing facility in Wilmington, MA. This position is vital in assuring that only product meeting defined quality and regulatory standards leaves the manufacturing location. This position requires a detail oriented individual capable of working independently in a clean room environment and with the demands of production timelines and commitments. This role has a schedule of Saturday to Wednesday, 8:00am - 4:30pm. You will be responsible for:Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.Support Wilmington manufacturing by performing duties such as incoming, in-process and final inspections, DHR or batch record completion, product release, etc.Authorize release of approved material, subassemblies and finished product.Prevent release of suspect or known nonconforming product and materials.Perform microbiological testing of environment and products as necessary.Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices.Follow detailed process steps without deviation.Organize reports, files, and results in a professional proficient manner.Complete training to Quality Systems processes as defined within the Sirtex learning management system.Be flexible and work within a small team in order to assure complete functional coverage.