Role Description The Pharmaceutical Laboratory Data Reviewer/Réviseur de données laboratoire pharmaceutique is a full-time, on-site role based at Pathogenia Lab in Dorval, QC. This role is responsible for reviewing, verifying, and approving analytical data generated in the laboratory to ensure accuracy, completeness, and compliance with internal SOPs and regulatory standards.
The person is expected to work in the afternoon shift starting at 2:00 pm.
Responsibilities
- Review complete analytical packages: spreadsheets, chromatograms, spectra, laboratory notebooks, raw data, and final reports.
- Verify the accuracy of calculations, transcriptions, and units.
- Confirm compliance with approved methods, SOPs, specifications, and protocols.
- Verify sample traceability and consistency with historical results (trends, OOT/OOS).
- Compliance and Data Integrity
- Ensure adherence to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate).
- Verify system access, audit trails, and data backups.
- Identify anomalies, incidents, deviations, or OOS/OOT results and initiate investigations in accordance with procedures.
- Participate in and/or lead Out of specifications Investigations OOS including Client communication
- Approve or reject analytical results within the quality system.
- Draft or contribute to incident reports, CAPAs, and root cause analyses.
- Ensure compliant archiving of analytical records.
- Quality Support and Continuous Improvement
- Participate in internal audits, external audits, and regulatory inspections.
- Contribute to updating SOPs, forms, and work instructions.
- Train and mentor analysts on good documentation practices and data integrity.
- Participate in periodic reviews of trends and quality indicators.
Qualifications
- Strong analytical and data review skills, with the ability to evaluate raw laboratory data, calculations, and reports for accuracy and consistency.
- Bachelor of Science degree (or equivalent combination of education and experience such as College with 5-10 years of pharmaceutical QC testing/records review experience) in Chemistry, Biochemistry or related biological science or equivalent in job experience.
- Over 2 years of experience working in a pharmaceutical regulated Laboratory environment or Pharmaceutical Company.
- Ability to work with electronic systems (eg. LIMS) and other lab equipment to be able to perform audit trail of testing records.
- Knowledge of GC, HPLC, UV, IR, ICP-MS/OES and other analytical instrument.
- Sound knowledge of Health Canada and FDA regulations.
- Quality Assurance /Quality control audit background in pharmaceutical industry is an asset
- Extended hours or weekend work may be required from time to time.
