Documentation Reviewer I
4 days ago
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 minimal supervision to ensure high-quality deliverables within agreed schedules.
- Verify the integrity and traceability of all data generated and reported, ensuring compliance with Good Manufacturing Practices (GMP) and regulatory requirements.
- Collaborate with scientists, chemists, and technicians to ensure that all necessary corrections are made in accordance with GMP standards.
- Notify department supervisors or 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.
- Bachelor of Science in Chemistry or a related science.
- Minimum 1 year of previous pharmaceutical analytical development experience.
- Previous document reviewer experience is preferred.
- Familiarity with current ALOCA principles.
- Experience with Empower software is required.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Basic understanding of common analytical technologies, including HPLC, GC, UV spectroscopy, titration, and raw material testing.
- Good written and oral communication skills.
- Understanding of GMP, ICH, and FDA requirements.
- Strong organizational skills and attention to detail.
- Ability to meet deadlines and prioritize tasks.
- Proficiency with Microsoft Office programs and the English language.
- 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 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 team performance 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.
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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Documentation Reviewer I
3 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Inc. Full timeJob SummaryWe 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 ResponsibilitiesReview technical documents with high quality and deliver within agreed...
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Documentation Reviewer I
3 days ago
Mississauga, Ontario, Canada Thermo Fisher Scientific Inc. Full timeJob SummaryWe 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 ResponsibilitiesReview technical documents with high quality and deliver within agreed...
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Mississauga, Ontario, Canada Thermo Fisher Scientific Full timeJob Summary:Thermo Fisher Scientific is seeking a highly skilled Documentation Reviewer I to join our team. As a Documentation Reviewer I, you will be responsible for independently reviewing various technical reports and raw data generated in our laboratories.Key Responsibilities:Review with minimum supervision all regular technical documents (batch testing,...
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