5 часов назад
QC Reviewer (Pharmaceutical QC)
50 000 - 60 000CAD
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
QC Reviewer (Pharmaceutical QC): Reviewing laboratory documentation and analytical testing records for pharmaceutical products with an accent on GMP compliance, data integrity, and electronic laboratory systems. Focus on leading OOS investigations, completing CAPAs, supporting audits and inspections, and improving Quality Control processes.
Location: Toronto, Ontario, Canada; relocation to Mississauga, Ontario, is expected in 2026
Salary: CAD 50,000–60,000 per year
Company
International life sciences organization providing analytical testing, laboratory, pharmaceutical, biopharmaceutical, environmental, food, and clinical research services through a global network of laboratories.
What you will do
- Review laboratory documentation, raw data, chromatographic records, calibration documents, and Quality Control records in accordance with GMP requirements.
- Verify data entries in laboratory systems and maintain data integrity before Certificates of Analysis are released in eLIMS.
- Participate in and lead Out of Specifications investigations and complete Corrective and Preventive Actions.
- Support internal, customer, and regulatory audits, inspections, and documentation reviews.
- Coach laboratory personnel on documentation issues and follow up on corrections required under GMP standards.
- Identify process improvements and contribute data to departmental KPI trending.
Requirements
- Bachelor of Science degree or equivalent education and experience in Chemistry, Biochemistry, or a related biological science.
- More than two years of experience in a pharmaceutical regulated laboratory or pharmaceutical company; alternatively, college education with 5–10 years of pharmaceutical QC testing or records review experience.
- Experience with electronic systems such as LIMS, laboratory equipment, and audit trails for testing records.
- Knowledge of GC, HPLC, UV, IR, ICP-MS/OES, and other analytical instruments.
- Knowledge of Health Canada and FDA regulations, with strong writing, language, and communication skills.
- Availability for rotating shifts, extended hours, or occasional weekend work.
Nice to have
- Quality Assurance or Quality Control audit experience in the pharmaceutical industry.
Culture & Benefits
- Full-time employment with health and dental coverage.
- Life and disability insurance.
- RRSP with a 3% company match.
- Paid holidays and paid time off.
- Start as soon as possible for the successful candidate.
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