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Documentation Reviewer I

2 months ago

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

We are seeking a highly skilled Documentation Reviewer I to join our team at Thermo Fisher Scientific Inc. As a key member of our quality assurance team, you will be responsible for reviewing technical documents and raw data generated in our laboratories.

Key Responsibilities
  • Review technical documents with high quality and deliver within agreed schedules.
  • Ensure test methods, protocols, and Standard Operating Procedures (SOPs) have been followed by scientists/chemists.
  • Verify the integrity and traceability of all data generated and reported.
  • Follow up with scientists/chemists/technicians to ensure necessary corrections are made in accordance with Good Manufacturing Practices' standard.
  • Notify department supervisor/manager regarding omissions, incomplete testing results, or other irregularities.
  • May be required to travel to different sites depending on business requirements.
  • Maintain a safe working environment and report potential hazards.
  • Perform alternating or rotating shift work as required.
Requirements
  • Bachelor of Science in Chemistry or related science.
  • Minimum 1 year of previous pharmaceutical analytical development experience.
  • Previous document reviewer experience preferred.
  • Familiar with current ALOCA principles.
Preferred Qualifications
  • Good written and oral communication skills.
  • Understanding of Good Manufacturing Practices, International Conference of Harmonization (ICH), and United States Food & Drug Administration (FDA) requirements.
  • Must have GMP chromatography experience (Specifically EMPOWER).
  • Direct pharmaceutical experience in a GMP environment.
  • Strong organizational skills and detail-oriented.
  • Ability to meet deadlines and prioritize.
  • Demonstrated computer proficiency with Microsoft Office programs.
  • Proficiency with the English Language.
Standards and Expectations
  • Follow all Environmental Health & Safety Policies and Procedures.
  • Work collaboratively with fellow team members, modelling 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.
  • Be client and patient conscious at all times.
  • Understand Key Performance Indicators and strive to improve the performance of the team by identifying areas for system improvements and engage in problem-solving.
  • Models positive thinking and is 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 strives to improve skills and knowledge in related field.
Physical Requirements

The position requires ordinary ambulatory skills and physical coordination sufficient to move about lab/lab office locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) 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.

Use of Personal Protective equipment may be required and may include any of the following: Safety glasses, safety shoes, lab coat, latex or similar gloves, safety apron, organic respirator occasionally.