Scientific Technical Writer

3 weeks 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 Development Laboratory, you will play a critical role in ensuring the accuracy and compliance of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications.

Key Responsibilities
  • Prepare technical documents, including method validation and transfer protocols, reports, analytical methods, and specifications, in accordance with regulatory, corporate, and industry standards.
  • Assist in the development of method transfer plans for incoming projects and provide input on the generation of these plans.
  • Document experimental data in accordance with ALCOA principles and maintain accurate and detailed records.
  • Perform analytical testing, including HPLC, dissolution, GC, and physical testing, following established procedures and SOPs.
  • Work proficiently with Empower, NuGenesis, MS Word, and Excel software.
  • Recognize and report unexpected or out-of-specification results 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 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.
  • Knowledge of regulatory requirements, including USP/NF and Ph. Eur.
  • Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint) and Chemstation and OpenLab.
  • Well-organized and detail-oriented with excellent interpersonal and communication skills.
  • Ability to work well independently and in a team environment with limited supervision.
  • Ability to prioritize multiple tasks and proficient in the English language.
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 Thermo Fisher Scientific quality systems SOPs and Good Manufacturing Practice (GMP).
  • Maintain workspace in a clean and orderly fashion.
  • Actively engage in and adhere to departmental systems to maintain a smooth and efficient workflow.
  • Be client and patient conscious at all times.
  • Understand Key Performance Indicators (KPIs) and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving.
  • Model positive thinking and be open to change, motivating the team to adapt to shifts in priorities and new ways of working.
  • Proactively identify areas for improvement in the execution of procedures.
  • Communicate risks to timelines in a proactive manner.
  • Consistently strive to improve skills and knowledge in related fields.
Physical Requirements

The position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations. The ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time is necessary. Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds is required. Arm, hand, and finger dexterity, including the ability to grasp and type for prolonged periods of time, is necessary. Visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time is required. The ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time is necessary. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, and organic respirator may be occasionally required.



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