Documentation Reviewer I

3 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 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.
  • Experience with Empower software required.

Working Conditions:

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.

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