Quality Assurance Technician

2 weeks ago


Wilmington Massachusetts, United States Sirtex Full time
Job Description

SCOPE:

The Wilmington plant is one of the global sites for Sirtex, and for production of SIR-Spheres microspheres for various markets. The position of QA 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 with the demands of production timelines and commitments. This role reports to the Quality Assurance Manager.

PRIMARY RESPONSIBILITIES:

Support Wilmington manufacturing by performing duties such as incoming, in-process and final inspections, DHR 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 product.

Work with beta-emitting radioactive material in a safe manner, adhering to provided guidelines and safeguards.

Ensure all activities are performed in accordance with Quality System requirements, work instructions and regulatory requirements.

Follow detailed process steps without deviation.

Organize reports, files, and results in a professional proficient manner.

Adhere to practices designed to protect both employees and product from contact and potential contamination, including suitable gowning and clean room practices.

Be flexible and work within a small team in order to assure complete functional coverage.

Complete training to Quality Systems processes as defined within the Sirtex learning management system.



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