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Job ID :
49206BR
Location :
US - Massachusetts - Bedford
:
Job Description

Key Responsibilities:

  • Initiate and administrate workflows in Oracle Agile system upon receipt of revision requests for all controlled document types (SOPs, forms, Quality Standards, Specifications, BOMs)
  • Issuance of revised documents including archival of superseded documents. Initiate routine document review workflows for controlled document types (SOPs, forms, quality standards)
  • Maintains training record, administrate training assignment resulted from change control. Create and maintain training matrix. Support other training processes as needed.
  • Review and approve production and quality control Batch Records. Perform batch release including: labeling, ERP transactions, document control, filing and other related tasks.

Requirements/Qualifications:

  • 3+ years of related work experience in quality assurance, document control, data entry and office administration
  • Knowledge of ISO9001 or 13485 document version control processes, policies and procedures
  • Ability to work independently or as part of a team, self-motivated, adaptable
  • Excellent communication and attention to detail
  • Experience with Oracle Agile PPM, Spartan TrackWise, SAP ERP/QM/LMS or other major electronic QMS tool highly desired
  • GMP Quality Assurance experience highly desired
  • Bachelor’s Degree a plus


*IND-LSG



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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