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Thermo Fisher Scientific QA Technician in Bedford, Massachusetts

Job Description

Job Title: QA Technician

Requisition ID: 106814BR

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

Location/Division Specific Information

Framingham, MA

How will you make an impact?

The Quality Assurance Technician role performs quality assurance related functions independently including but not limited to documentation review of product releases and maintaining this documentation in accordance with ISO 13485 and ThermoFisher policies and procedures. You will support and provide guidance to the adherence of in-house processes and procedures in order to maintain safety according to EH&S requirements. Minor traveling is required to support operations as part of the quality assurance team.

What will you do?

  • Review and approve production and quality control Batch Records. Performs Batch Release in compliance with internal SOPs and ISO standards

  • Conduct Real Time batch record Reviews on the floor, in order to provide feedback and facilitate compliance to GDP and cGMP activities

  • Perform internal audits of operational areas to ensure compliance as per procedures and policies.

  • Manage time effectively in order to support the QA team

  • Must be flexible in order to meet the needs of Operations

  • Must be able to support multi sites (minimal travel required)

  • Be able to collaborate, communicate and work effectively with multiple teams on issues that arise: related to product quality, procedural compliance, and other business activities

  • Facilitate Deviation process through daily interaction with Process and QA owners

  • Works directly with investigation teams on critical quality issues

  • Support activities within the Quality Management System as required

How will you get here?

Associates degree from accredited college/university or equivalent experience. Science or Engineering Degree preferred.

Education

  • Minimum of 3 years of relevant Quality/manufacturing/engineering experience in a regulated industry

  • Knowledge of Quality standards (e.g. ISO 13485)

  • Knowledge of Global Systems (e.g. TrackWise, AGILE, E1, SAP) preferred

Knowledge, Skills, Abilities

  • Ability to work independently or as part of a team, self- motivated, adaptable

  • Excellent communication and Attention to Detail

  • Be able to work in a fast paced environment

At Thermo Fisher Scientific, each one of our 70,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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