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Job ID :
61763BR
Location :
US - California - Fremont
:
Job Description

Position Summary:

The Manufacturing Document Specialist will be responsible for the coordination of activities required to provide excellent manufacturing documentation and standard operations procedure (SOPs). Activities include updating and revising manufacturing process instructions (MPIs) to support the manufacturing system, facilitating and controlling changes to manufacturing & SOP documentation, maintaining complete, accessible and traceable records of documentation change, controlling the distribution of current manufacturing and SOP document revisions, and the maintenance of obsolete documentation.


Key Responsibilities:

  • Review and edit manufacturing process documentation for compliance, consistency in content, and ease of use. Interact with appropriate departments to resolve discrepancies
  • Assist in implementation and maintenance of Manufacturing Process Instructions (MPIs), bill of material, Batch Record Sheets, and other documents.
  • Track change progress and be familiar with status. Provide notification to appropriate personnel once approved.
  • Assist in implementation and maintenance of departmental SOPs
  • Review and create Change Orders as per red lined documents provided by Managers, Supervisors or team leads.
  • Assist and aid in NCAR and CAPA investigations or Action Items resulting from NCAR/CAPAs.
  • Assist and aid in required SOP and form reviews to ensure compliance with required formatting.
  • Perform all job duties in a safe manner and obeys all safety policies and procedures
  • Perform all job duties consistent with the Code of Ethics and the 4-I values
  • Perform all job duties within ISO standards, regulatory or statutory requirements
  • Perform other duties and cross training as assigned


Minimum Requirements/Qualifications:

  • Must have good communication skills, both written and oral, with advanced word processing skills
  • 2-4 years experience in quality or document control functions
  • Must be detail-oriented and accurate
  • Must be fluent with computer operations and be able to work well with associates. Analytical, problem-solving skills required
  • Experience working with manufacturing documentation
  • Comprehensive knowledge of chemical product documentation
  • High school diploma or GED required


Physical Requirements:
  • Able to work in Manufacturing environment.
  • Position requires frequent communication and walking to other areas in which designated PPE will be required.
  • Position will require sitting and standing.
  • Employee may occasionally lift and/or move up to 40 pounds.


Non-Negotiable Hiring Criteria:

  • Requires good written and verbal communication skills
  • Excellent problem solving skills
  • Strong computer skills

This position is not approved for relocation benefits.


As the world’s leader in serving science, Thermo Fisher Scientific is a driving force in the research, healthcare, industrial and applied markets, generating more than $18B in annual revenue. No other company can match our range of customer touch points – technologically, geographically or commercially. We help our customers in finding cures for cancer, protecting the environment, making sure our food is safe and moving forward with thousands of important projects that improve millions of lives.


At Thermo Fisher Scientific, each one of our 65,000 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.




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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