Thermo Fisher Scientific Change Control Analyst in Fremont, California

Job Description

Position Summary:

Thermo Fisher is looking for a self-driven Change Control Analyst. This position requires at least one year experience in the administration of the change control and/or document control process. The candidate will liaise with Project Managers, change requestors, management and operational teams concerning change requests, checking accuracy of content, status, and compliance with cGMP documentation practices.

Responsibilities:

  • Ability to maintain confidential information, to meet deadlines, manage priorities, accuracy and attention to detail is critical.

  • Assure that change records are readily retrievable and in inspection-ready condition.

  • Checks and verifies that change orders are accurate, properly cross reference all affected documents, and meet requirements for compliance with external customers, internal documentation and cGMP documentation practices.

  • Demonstrated proficiency level with Microsoft Office products required.

  • Demonstrates understanding of Quality Systems fundamentals, Electronic Quality Systems Management Systems (eQMS) (preferably MasterControl);

  • Demonstrates knowledge of the process, effects, and the relationship between the change process and products, and understanding of current Medical Device industry and applicable regulations including 21CFR820, ISO 13485, ISO 14971;

  • Coordinates sending out task emails, scheduling preproduction meetings between Engineering and Production, Marketing, QA, QC and submitting of Change orders for approval;

  • Supports the correct and timely implementation of Change Requests;

  • Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues;

  • Provides support to internal and regulatory audits/inspections as required.

Required Knowledge - Skills - and Abilities:

  • BS Degree or equivalent with minimum of 2 to 4 years of experience in change and/or document control administration.

  • MS with 0-2 years of experience in the medical device, biopharmaceutical/pharmaceutical or a related industry.

  • Medical device, biotechnology, biopharmaceutical, pharmaceutical or in a Life Science/regulated industry experience is required.

  • Demonstrates understanding of Quality Systems fundamentals, electronic Quality Systems Management Systems (eQMS) (preferably MasterControl).

  • Demonstrates knowledge of the process, effects, and the relationship between the change process and products, and understanding of current Medical Device industry and applicable regulations including 21CFR820, ISO 13485, ISO 14971.

  • Ability to convince and influence others.

  • Demonstrated proficiency level with Microsoft Office products required.

  • Typing at least at 40 wpm

  • Good written and verbal communication skills.

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.