ThermoFisher is seeking a meticulous Documentation Reviewer to join our team. In this role, you will be responsible for independently reviewing pharmaceutical laboratory documentation, raw data, and analytical reports generated in Lab Operations, ensuring all work meets GMP requirements.
What You'll Do
- Review routine pharmaceutical laboratory technical documents and associated raw data with minimal supervision, ensuring high quality and timely delivery.
- Verify that laboratory chemists properly follow test methods, protocols, and Standard Operating Procedures (SOPs).
- Check the integrity, accuracy, and traceability of all data generated and reported by laboratory chemists.
- Follow up with laboratory chemists to ensure all required corrections are addressed in compliance with GMP standards.
- Notify the department supervisor of any omissions, incomplete results, or other irregularities.
- Maintain a safe working environment, report potential hazards, and follow all Environmental Health & Safety policies.
- Perform afternoon shift work and travel to different sites as required by business needs.
- Work collaboratively with team members, modeling positive behaviors to meet project and departmental objectives.
- Perform all duties in strict compliance with ThermoFisher quality systems SOPs and GMP requirements.
- Maintain a clean and orderly workspace and engage with departmental systems to support efficient workflow.
- Maintain a strong client and patient focus, understand team KPIs, and contribute to performance improvement initiatives.
- Demonstrate adaptability to change, proactively identify improvement opportunities, and communicate risks to timelines.
- Continuously develop your skills and knowledge within the field.
What We're Looking For
- A Bachelor of Science in Chemistry or a related scientific discipline.
- 1–3 years of experience in a pharmaceutical analytical laboratory.
- Equivalent combinations of education, training, and relevant work experience may be considered.
- Familiarity with laboratory analytical technologies, including HPLC, GC, UV spectroscopy, titration, and raw material testing.
- GMP chromatography experience, specifically with Empower software.
- Direct pharmaceutical laboratory experience in a GMP-regulated environment.
- Understanding of GMP, ICH guidelines, and FDA requirements.
- Strong organizational skills and exceptional attention to detail.
- Ability to prioritize tasks and meet deadlines effectively.
- Strong written and verbal communication skills.
- Demonstrated proficiency in Microsoft Office applications.
- Proficiency in English.
Technical Stack
- Empower software
- LIMS
- HPLC
- UV instrumentation
- pH meters
- Microsoft Office
- Smartsheet
Team & Environment
You will report directly to the Department Supervisor, working closely with laboratory chemists and other team members to ensure quality and compliance.
Compensation
The salary range for this position is $41,900.00–$62,900.00.
Work Mode
This is an onsite position based in Ontario.
ThermoFisher is an equal opportunity employer.
