GENERAL DESCRIPTION:
The QC Data Reviewer is responsible for the independent review of analytical, microbiological, and all other data generated within the Quality Control (QC) laboratory to ensure accuracy, completeness, and compliance with Good Manufacturing Practices (GMP), internal procedures, and regulatory requirements. This role ensures that any deviations, anomalies, or errors are properly documented and addressed. The QC Data Reviewer guarantees that laboratory data supporting raw materials, in-process samples, stability samples, and finished products are reliable and meet quality standards prior to release.
DUTIES/RESPONSIBILITIES:
- Perform detailed review of laboratory data for accuracy, completeness and compliance with applicable SOPs, GMP, GDP, and regulatory requirements.
- Review electronic laboratory data and audit trails within reporting systems such as data acquisition software and ERP systems
- Verify calculations, chromatography reports, system suitability assessments, inspections records, etc., from corresponding electronic and paper records.
- Confirm that all reported results are within specification; notify appropriate parties of any out-of-specification (OOS) results and initiate quality events as required.
- Identify and investigate data discrepancies, anomalies, or trends. Collaborate with lab personnel to resolve data-related issues and improve data quality.
- Conduct reviews and approvals in a timely manner to support production timelines, collaborating across departments to prioritize needs.
- Authorize written and electronic approvals for COAs, batch record documentation, and analysis reports.
- Review and approve calibration and preventive maintenance logs/reports from internal and external assessments.
- Apply and enforce data integrity procedures to ensure QC documentation adheres to internal and regulatory expectations from agencies such as FDA, Health Canada, and other applicable authorities.
QUALIFICATION REQUIREMENTS:
Education/Experience:
- Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Microbiology, or a related scientific discipline.
- Minimum 2 years relevant experience in regulated industries
- Proficiency in analytical chromatographic techniques is an asset
Skills/Knowledge/Licences:
- Ability to work both independently and as part of a team in a fast-paced production environment
- Familiarity with Health Canada and FDA regulatory requirements for OTC and cosmetic products.
- Exceptional attention to detail with strong written communication skills in English.
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint); experience with electronic Quality Management Systems (QMS) is an asset.
- Well-developed problem-solving, organizational, and time-management abilities.
Job Types: Full-time, Fixed term contract
Pay: From $24.00 per hour
Benefits:
- Company events
- Company pension
- Dental care
- Employee assistance program
- Extended health care
- Life insurance
- On-site parking
- Vision care
Work Location: In person
