QC Reviewer - BioPharma Product Testing

About the role

Eurofins BioPharma Product Testing in Toronto is hiring a full-time QC Reviewer. The role reviews laboratory documents and data in the Quality Control Laboratory according to GMP requirements, ensuring data integrity before the Certificate of Analysis (CoA) is released in eLIMS.

Key responsibilities

• Review finished products, bulk, raw materials and stability study products in a timely manner as per GMP requirements.
• Check the accuracy of data entries in raw data and chromatographic data management systems before releasing the CoA in eLIMS.
• Complete training assignments and keep personal training records.
• Take part in and/or lead out-of-specification investigations and complete CAPAs.
• Take part in internal, customer and regulatory audits and assist laboratory personnel with documentation issues.
• Support regulatory inspections and follow up on corrections made by analysts and technicians.
• Identify and implement process improvements and ensure test methods, protocols and SOPs were followed.
• Audit calibration and other QC documents, input data for departmental KPI trends, and report irregularities to the supervisor or manager.
• May require alternating or rotating shifts, extended hours or weekend work.

Required profile

• Bachelor of Science (or equivalent education and experience) in Chemistry, Biochemistry or a related biological science, or equivalent job experience.
• More than 2 years of experience in a pharmaceutical regulated laboratory or pharmaceutical company.
• Ability to work under pressure; excellent writing and communication skills.
• Knowledge of Health Canada and FDA regulations; QA/QC audit background is an asset.

Required skills

• Working with electronic systems such as LIMS and performing audit trails of testing records.
• Knowledge of GC, HPLC, UV, IR, ICP-MS/OES and other analytical instruments.

What we offer

• Full-time benefits including health and dental coverage, life and disability insurance, RRSP with a 3% company match, paid holidays and paid time off.
• Relocation to Mississauga, ON is expected in 2026.