Documentation Reviewer

1 month ago

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

We are seeking a highly skilled Documentation Reviewer 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 minimal supervision to ensure high-quality deliverables.
  • Verify that test methods, protocols, and Standard Operating Procedures (SOPs) have been followed by scientists/chemists.
  • Ensure the integrity and traceability of all data generated and reported.
  • Collaborate with scientists/chemists/technicians to ensure necessary corrections are made in accordance with Good Manufacturing Practices (GMP) standards.
  • 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.
Preferred Qualifications
  • Equivalent combinations of education, training, and relevant work experience may be considered.
  • Basic understanding of common analytical technologies (HPLC, GC, UV spectroscopy, titration, and raw material testing).
  • Good written and oral communication skills.
  • Understanding of Good Manufacturing Practices, International Conference of Harmonization (ICH), and United States Food & Drug Administration (FDA) requirements.
  • GMP chromatography experience (specifically Empower is an asset).
  • 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

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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