Senior QC/QA Technician

SCOPE:

The position of Senior Quality Control/Assurance Technician 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 meeting the demands of production timelines and commitments. This position requires the successful candidate to be onsite in our Wilmington, MA facility.  This position is responsible for:

PRIMARY RESPONSIBILITIES:

• Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.
• Support manufacturing by performing duties such as incoming, in-process, final inspections, DHR completion, Quality Control testing, product release, etc.
• Authorize release of approved material, intermediates and finished product
• Prevent release of suspect or known nonconforming products 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.
• Conduct training to Quality Systems processes as defined within the Sirtex learning management system.
• Be flexible and work within a small team without strictly defined roles to assure complete functional coverage