Documentation Reviewer I

3 days 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 and verifying technical reports and raw data generated in our laboratories.

Key Responsibilities
  • Review and verify technical reports and raw data with minimal supervision to ensure high-quality deliverables within agreed schedules.
  • Ensure that test methods, protocols, and Standard Operating Procedures (SOPs) have been followed by scientists and technicians.
  • Verify the integrity and traceability of all data generated and reported.
  • Collaborate with scientists and technicians to ensure that all necessary corrections are made in accordance with Good Manufacturing Practices (GMP) standards.
  • Notify department supervisors and managers 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 a related science.
  • Minimum 1 year of previous pharmaceutical analytical development experience.
  • Previous document reviewer experience preferred.
  • Familiarity with current ALOCA principles.
  • Experience with Empower software is required.
Preferred Qualifications
  • Equivalent combinations of education, training, and relevant work experience may be considered.
  • Basic understanding of common analytical technologies, including High Performance Liquid Chromatography (HPLC), Gas Chromatography, Ultraviolet (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.
  • Strong organizational skills and attention to detail.
  • Ability to meet deadlines and prioritize tasks.
  • 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 Thermo Fisher Scientific quality systems SOPs and Good Manufacturing Practice (GMP).
  • Maintain a clean and orderly workspace.
  • Actively engage in and adhere to departmental systems 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.
  • Model positive thinking and be 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 strive to improve skills and knowledge in related fields.
Physical Requirements

The position requires ordinary ambulatory skills and physical coordination sufficient to move about laboratory and office locations. The ability to stand, walk, stoop, kneel, and crouch periodically for prolonged periods of time is necessary. 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 also required. The ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time is necessary. Use of Personal Protective Equipment (PPE) 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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