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Quality Assurance Specialist

2 months ago

Wilmington Massachusetts, United States Sirtex Full time
Job Overview

The Quality Assurance Specialist plays a crucial role in maintaining the integrity of products at Sirtex. This position is essential for ensuring that all products meet established quality and regulatory benchmarks before they are dispatched from the manufacturing facility.

This role demands a meticulous individual who can operate autonomously in a controlled environment while managing the pressures of production schedules.


Key Responsibilities:


Assist in the manufacturing process by conducting various inspections, including incoming, in-process, and final assessments, as well as completing necessary documentation for product release.


Perform visual assessments, measurements, and functional evaluations utilizing calibrated tools and instruments, ensuring that results are accurately documented in accordance with company protocols.

Authorize the release of verified materials, subassemblies, and finished goods.


Identify and report any non-conforming products or materials to prevent the release of potentially defective items, facilitating prompt corrective measures.

Conduct microbiological assessments of both the environment and products.

Manage equipment oversight tasks, including calibration and routine maintenance.

Safely handle beta-emitting radioactive materials while adhering to established safety guidelines and protocols.

Ensure compliance with Quality System standards, work instructions, and regulatory mandates throughout all activities.

Follow prescribed procedures meticulously without deviation.

Maintain organized records, files, and results in a professional manner.


Adhere to practices designed to safeguard both personnel and products from contamination, including appropriate gowning and cleanroom protocols.

Demonstrate flexibility and collaborate within a small team to ensure comprehensive functional coverage.

Complete training on Quality Systems processes as outlined in the Sirtex learning management system.