Scientific Technical Writer

1 week ago

Mississauga, Ontario, Canada ThermoFisher Scientific Full time
Job Summary

We are seeking a highly skilled Scientific Technical Writer to join our team at Thermo Fisher Scientific. As a Scientific Technical Writer, you will play a critical role in assisting with the preparation of analytical method validation protocols and reports, method transfer protocols and reports, analytical methods, and specifications used by the Development Laboratory.

Key Responsibilities
  • Technical Document Preparation: Assist with the preparation of technical documents such as method validation and transfer protocols, reports, analytical methods, and specifications.
  • Method Transfer Planning: Help provide input on the generation of method transfer plans for incoming projects.
  • Experimental Data Documentation: Document all experimental data in accordance with Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) principles.
  • Analytical Testing: Independently carry out HPLC, dissolution, GC, and physical testing analysis following established procedures and Analytical Methods & Standard Operating Procedures (SOPs).
  • Software Proficiency: Work proficiency with Empower, NuGenesis, MS Word, and Excel software.
  • Quality Assurance: Recognize and report unexpected or Out Of Specification (OOS) results immediately to the Supervisor and conduct laboratory investigations under direction.
  • Lab Safety: Maintain a safe working environment and report potential hazards.
  • Flexibility: Perform alternating or rotating shift work as required.
Requirements
  • Education: Bachelor of Science (B.Sc.) in Chemistry or a related science.
  • Experience: Minimum 3 years' pharmaceutical laboratory work experience.
  • Technical Document Preparation: Experience in the preparation of technical documents.
  • Laboratory Testing: Experience in laboratory testing and method validation.
  • Equivalency: Equivalent combinations of education, training, and relevant work experience may be considered.
Knowledge, Skills, and Abilities
  • Analytical Method Validation: Strong knowledge of analytical method validation requirements.
  • Regulatory Compliance: Excellent Good Manufacturing Practices, Good Laboratory Practices (GLP), International Conference on Harmonization (ICH), and United States Food and Drug Administration (FDA) compliance knowledge.
  • Regulatory Requirements: Knowledge of regulatory requirements including USP/NF and Ph. Eur.
  • Software Proficiency: Proficient in Microsoft Office Suite (Word, Excel, and PowerPoint), Chemstation, and OpenLab.
  • Communication: Excellent interpersonal and communication skills (both oral and written).
  • Teamwork: Ability to work well independently and in a team environment with limited supervision.
  • Time Management: Ability to prioritize multiple tasks.
  • Language: Proficient with the English language.
Standards and Expectations
  • Environmental Health & Safety: Follow all Environmental Health & Safety Policies and Procedures.
  • Teamwork: Work collaboratively with fellow team members, modeling positive team principles and partnering to meet project and departmental objectives.
  • Quality Systems: Carry out all duties within strict compliance to Patheon quality systems SOP's and Good Manufacturing Practice (GMP).
  • Workspace Maintenance: Maintain workspace in a clean and orderly fashion.
  • Client Focus: Be client and patient conscious at all times.
  • Continuous Improvement: Understand Key Performance Indicators (KPI's) and strive to improve the performance of the team by identifying areas for system improvements and engaging in problem-solving.
  • Adaptability: Model positive thinking and be open to change, motivating the team to adapt to shifts in priorities and new ways of working.
  • Risk Management: Proactively identify areas for improvement in the execution of procedures.
  • Communication: Communicate risks to timelines in a proactive manner.
  • Professional Development: 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 required. Manipulation (lift, carry, move) of light to medium weights of 10-35 pounds is also 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 also necessary. Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, and organic respirator may be occasionally required.

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