Quality Assurance Specialist

2 weeks ago


Mississauga ON, Canada Hudson RPO Full time

About the Company:

We are assisting our client in their search for a talented and dedicated Quality Assurance Specialist to join their manufacturing team.

Role Overview: Quality Assurance Specialist

As a Quality Assurance Specialist, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) and maintaining the highest standards of quality assurance throughout the product lifecycle. Your primary focus will be on reviewing and releasing products, conducting investigations into complaints and deviations, and ensuring the accuracy and compliance of batch records.

Key Responsibilities:

  • Review and Release: Review batch records and associated documentation to ensure compliance with quality procedures and standards. Release or reject batches based on established criteria and regulatory requirements
  • Compliance Assurance: Ensure adherence to Good Manufacturing Practices (GMP) and other regulatory guidelines, maintaining compliance with industry standards and regulations
  • Quality Assurance (QA): Develop and implement quality assurance procedures, including Standard Operating Procedures (SOPs), to uphold quality standards and ensure consistency in product quality
  • Investigations: Conduct thorough investigations into product complaints, deviations, and incidents to identify root causes and implement corrective and preventive actions (CAPAs) as necessary
  • Batch Record Review: Perform meticulous reviews of batch records and documentation, verifying accuracy, completeness, and compliance with regulatory requirements

Qualifications:

  • Bachelor of Science (B.S.) degree (or equivalent experience)
  • Proven experience in quality assurance or a related field, preferably in a GMP-regulated industry
  • Strong understanding of GMP regulations and quality management systems
  • Experience conducting investigations, root cause analysis, and implementing CAPAs
  • Excellent attention to detail and analytical skills
  • Effective communication skills, with the ability to collaborate cross-functionally

Note: Sponsorship and relocation assistance are not available for this position.



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