Document Reviewer II - QA - Afternoon
On-site · Whitby, Ontario, Canada
Job Summary
Document Reviewer II on the QA team responsible for reviewing data, lab notebooks, Certificates of Analysis, and Stability reports generated in the Laboratory. Verify data integrity and traceability of all data; review technical documents such as batch testing, stability testing, method development and validation, and raw materials/packaging components. Ensure SOPs and test methods are followed, coordinate with scientists to correct omissions per GMP standards, and update SOPs and initiate change control when needed. Maintain safety and quality by adhering to schedules, environmental health and safety policies, and performing occasional rotating shifts. Proficiency in TrackWise OOS/DR reviews, SAP release processes, LIMS usage, and Empower; strong knowledge of HPLC, GC, UV, titration, and related QC analytical technologies. Communicate risks to timelines, support problem solving and continuous improvement, and model teamwork. Requirements include a Bachelor’s in Chemistry or related field, 3 years of pharma analytical development experience, strong documentation and regulatory knowledge, and excellent communication skills. Compensation in Ontario ranges from CAD 50,800 to 70,000 per year. Equality and accommodation policies are noted. The role emphasizes data integrity, GMP compliance, and collaboration within the laboratory and QA teams.
Required Qualifications
- Bachelor of Science in Chemistry or related science
- Minimum 3 years of previous pharmaceutical analytical development experience
- Knowledge of HPLC, GC, UV spectroscopy, titration
- Experience with TrackWise, SAP, LIMS, Empower
- Excellent written and oral communication skills
- Understanding of GMP, ICH, FDA requirements
- Strong organizational and detail-oriented skills
- Ability to meet deadlines and prioritize
- Proficiency with Microsoft Office; English language
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