Scientific Technical Writer

5 days ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time
Job Summary

We are seeking a highly skilled Scientific Technical Writer to join our team at Thermo Fisher Scientific. As a key member of our laboratory team, you will be responsible for assisting with the preparation of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications.

Key Responsibilities
  • Assist with the preparation of technical documents, including method validation and transfer protocols, reports, analytical methods, and specifications.
  • Provide input on the generation of method transfer plans for incoming projects.
  • Document all experimental data in accordance with ALCOA (Attributable, Legible, Contemporaneous, Original, and Accurate) principles.
  • Independently carry out HPLC, dissolution, GC, and physical testing analysis following established procedures and analytical methods.
  • Work proficiently with Empower, NuGenesis, MS Word, and Excel software.
  • Recognize and report unexpected or out-of-specification results immediately to the supervisor and conduct laboratory investigations under direction.
  • Maintain a safe working environment and report potential hazards.
  • Perform alternating or rotating shift work as required.
Requirements
  • Bachelor of Science degree in Chemistry or a related science.
  • Minimum 3 years' pharmaceutical laboratory work experience.
  • Experience in the preparation of technical documents.
  • Experience in laboratory testing and method validation.
Preferred Qualifications
  • Strong knowledge of analytical method validation requirements.
  • Excellent knowledge of Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH), and United States Food and Drug Administration (FDA) compliance.
  • Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint) and Chemstation and OpenLab software.
  • Well-organized and detail-oriented with excellent interpersonal and communication skills.
Standards and Expectations
  • FOLLOW ALL ENVIRONMENTAL HEALTH & SAFETY POLICIES AND PROCEDURES.
  • WORK COLLABORATIVELY WITH FELLOW TEAM MEMBERS, MODELING POSITIVE TEAM PRINCIPLES AND PARTNERING TO MEET PROJECT AND DEPARTMENTAL OBJECTIVES.
  • CARRY OUT ALL DUTIES WITHIN STRICT COMPLIANCE TO PATHEON QUALITY SYSTEMS SOP'S AND GOOD MANUFACTURING PRACTICE (GMP).
  • MAINTAIN WORKSPACE IN A CLEAN AND ORDERLY FASHION.
  • ACTIVELY ENGAGE IN AND ADHERE TO DEPARTMENTAL SYSTEMS IN ORDER TO MAINTAIN A SMOOTH AND EFFICIENT WORKFLOW.

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