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BILINGUAL Quality Assurance Associate

3 months ago

Toronto, Canada Insight Global Full time

JD - BILINGUAL ROLE - BILINGUAL QUALITY ASSURANCE ASSOCIATE

Insight Global is looking for a QA associate to join a leading scientific international testing company under their QA, Compliance and regulatory consulting division. The QA Associate will be responsible for providing documentation and technical support for designated clients under the supervision of Senior Quality Consultant and Manager, Regulatory and QA Consulting. Duties similar to a Scientific Data Clerk.


This opportunity gives candidates an amazing opportunity to get in with a large respected Scientific laboratory testing and analytical company with immense room for growth and advancement Looking for new grads or people seeking entry level roles.


This is a 1 year contract that will convert to a fulltime position.


Responsibilities-

  • MUST BE BILINGUAL
  • Review and reconcile Good Manufacturing Practices (GMP) documents ensuring compliance. including production documents and QC disposition (Batch records, Certificates of Analysis/Manufacture, Product Label Reviews). Make sure they are compliant by conducting doc assessment.
  • Track and maintain GMP documents; initiate and update client SOPs.
  • Coordinate product release, confirming quality and GMP compliance.
  • Implement confirmatory testing for imported products as per Canadian standards.
  • Review warehouse reports and ensure proper handling of products (transportation, sampling, storage, destruction).
  • Maintain familiarity with client contracts and establishment licenses, including foreign sites.
  • Assess and trend product stability programs to ensure compliance.
  • Assist with investigations related to deviations, CAPA, and out-of-specifications.
  • Manage change controls, complaints, adverse events, recalls, and assess damaged/returned goods.
  • Assist with validation protocols/reports for transportation, temperature mapping, and stability studies.
  • Conduct self-inspections and support external inspections.
  • Adhere to SOPs and company service standards; attend audits and staff meetings.
  • Ensure accurate inventory control and distribution records.
  • Perform additional duties as delegated by management.



Required skills

  • Fluent in both French and English.
  • 1+ year in a Good Manufacturing Practices (GMP) Role
  • Batchelor's Degree in Chemistry, Microbiology, Biochemistry, or a diploma in a related field; or diploma in quality operations of Pharma Products.
  • Experience doing Document assessment to ensure compliance with regulations.
  • Proficient in MS Office (especially Excel)


Nice to have

  • Experience working in a contract laboratory is considered an asset.
  • Experience working with Pharmaceuticals, Natural Health Products, and Medical Devices is an asset;