9am-7pm)

Sirtex•Wilmington, MA

8d•$59,000 - $75,000•Onsite

About The Position

The Senior Quality Control/Assurance Technician plays a crucial role in ensuring that products meeting defined quality and regulatory standards are released from the manufacturing location. This position requires a detail-oriented individual capable of working independently in a clean room environment and meeting production timelines. The role involves supporting manufacturing through various duties such as incoming, in-process, and final inspections, DHR completion, Quality Control testing, and product release. The successful candidate will authorize the release of approved materials and finished products, prevent the release of nonconforming products, and perform microbiological testing. Adherence to practices that protect employees and product from contamination, including proper gowning and clean room practices, is essential. The role also involves organizing reports and files, conducting training on Quality Systems processes, and demonstrating flexibility to work within a small team without strictly defined roles to ensure complete functional coverage.

Requirements

Minimum of a High school degree required
Fluent in English (read, write and speak)
Ability to learn and successfully execute tasks such as visual inspection and testing utilizing basic laboratory equipment
3+ years’ experience handling chemicals and using basic chemical laboratory equipment.
3+ years’ experience working in a medical device, pharmaceutical, or other regulated industry required.
Personable, energetic, responsive and confident
Strong organization and time management skills
Self-starter with the ability to learn and work as part of a team.
Strong verbal, written, analytical, persuasive skills and ability to interact effectively with all levels
Strong interpersonal skills, energetic, proactive, flexible with high integrity and ethics in all dealings
Basic office computer skills (email, word processing, and spreadsheet software)

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