23 days old

QA Specialist II (Change Control Coordinator)

Galesburg, IL 61401
Location :
US - Utah - Logan
Job Description

When you join us at Thermo Fisher Scientific, you’ll be part of a smart, driven team that shares your passion for exploration and discovery. With revenues of $22 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.

Key Responsibilities:

  • Manage the Change Control system (90% time allocation), which includes:
    • Lead on all Change Control meetings
    • Input of all Change Requests into a tracking system
    • Following up on open changes with owners to ensure they are resolved and dispositions are made in a timely manner
    • Generate and monitor metrics for report out in Management Review and use these metrics to address improvement opportunities.
    • Improving the Change Control system as it moves into a more automated database
    • Own Change Control procedures
    • Train to Change Control processes and tools
  • Familiarity with CAPA as required by ISO 13485
  • Participate in other QMS efforts such as CAPA, Non-conformances, document control, training, supplier quality, etc.
  • Participate in PPI (continuous improvement) events
  • Perform other duties as assigned (10% time allocation):
    • Review all lot records prior to release
    • Release Manufacturing Lots
    • Participate & Maintain Investigative Processes (PNs, Deviations, CAPA)
    • Participate in self inspection activities as assigned
    • Generate COA Templates

Quality Responsibilities:

  • Observes all departmental and Quality System procedures and work instructions.
  • Supports Thermo Fisher Scientific’s commitment for continuous improvement by documenting process improvement opportunities thorough the Quality System.

Minimum Requirements/Qualifications:

  • Associate Degree ( or equivalent work experience in cGMP field (5 yrs) )
  • Ability to work independently with little direct supervision
  • General project management skills
  • General knowledge of computer systems
  • Experience working in cGMP environment
  • General knowledge of ISO 13485
  • Organization Skills
  • Attention to detail
  • Problem solving skills
  • General knowledge of change control function

Non-Negotiable Hiring Criteria:

  • Associate Degree or equivalent work experience in cGMP field (5 yrs)
  • General knowledge of computer systems
  • General project management skills

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.

If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here 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.


Posted: 2019-11-18 Expires: 2019-12-18

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QA Specialist II (Change Control Coordinator)

Galesburg, IL 61401

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