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Scientific Technical Writer

2 months 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 principles.
  • Independently carry out HPLC, dissolution, GC, and physical testing analysis following established procedures and SOPs.
  • Work proficiently with Empower, NuGenesis, MS Word, and Excel software.
  • Recognize and report unexpected or OOS 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 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, and regulatory requirements.
  • Proficient in Microsoft Office Suite and laboratory software.
  • Well-organized and detail-oriented with excellent interpersonal and communication skills.
Working Conditions

The position requires ordinary ambulatory skills and physical coordination sufficient to move about the lab/lab office locations. Ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time. Manipulation of light to medium weights of 10-35 pounds. Arm, hand, and finger dexterity, including ability to grasp and type for prolonged periods of time. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time. Ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.