Documentation Reviewer I

4 weeks ago

Mississauga, Ontario, Canada Thermo Fisher Scientific Full time

Job Summary

We are seeking a highly skilled Documentation Reviewer I to join our team at Thermo Fisher Scientific. 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 and raw data with high quality and deliver within agreed schedule.
  • 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 all 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

  • Direct pharmaceutical experience in a GMP environment.
  • Strong organizational skills and detail-oriented.
  • Ability to meet deadlines and prioritize.
  • 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, 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.
  • 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 engaging 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 fields.

Physical Requirements

  • 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.

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