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Technical Writer

Thermo Fisher Scientific · Allentown, PA

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Role summary

Thermo Fisher Scientific seeks a Technical Writer to serve as a subject matter expert in quality assurance and compliance within their Clinical Quality Assurance department. The role involves auditing processes, leading corrective actions, reviewing analytical data and batch records, and supporting regulatory inspections in an office and laboratory environment.

What they're looking for

  • Bachelor's degree or equivalent formal academic/vocational qualification
  • 5+ years of laboratory or quality assurance experience
  • Expertise in quality management systems and GxP compliance
  • Trackwise experience preferred
  • Ability to lead vendor and internal audits
  • Strong data review and analytical skills

What you'll be doing

  • Serve as subject matter expert for process audits, computer system validation, and batch record reviews
  • Represent department in client and regulatory inspections; develop and track corrective actions
  • Review analytical reports and batch records for data completeness, accuracy, and compliance
  • Provide training to department and laboratory staff in quality management areas
  • Lead risk assessments and mentor junior team members

Privacy & handoff

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What RoleLantern checked

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RoleLantern checked active
RoleLantern checkedNeeds clarity
Date posted13 days ago
Last source check1 day ago
Salary listedNeeds clarity
Location clearClear
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