Quality Assurance Specialist

6 days ago

Winnipeg, Manitoba, Canada Emergent BioSolutions Full time
Job Summary

The Quality Assurance Deviations and CAPA Specialist plays a crucial role in ensuring the quality and compliance of our products at the Winnipeg facility. This position provides technical expertise in quality systems, manufacturing, quality control, supplier quality management, and product development activities.

Key Responsibilities
  • Deviation Management: Manage deviations and corrective/preventative actions to ensure compliance with regulatory requirements.
  • Quality Systems Reports and Improvement Projects: Provide technical expertise and advanced Quality Systems knowledge to support QA Management in ensuring the primary objective of manufacturing safe products.
  • Change Actions Review and Approval: Review and approve change actions to ensure compliance with GMP requirements and Emergent's procedures.
  • Compliance with GMP Requirements: Ensure compliance with Good Manufacturing Practices (GMP) requirements, good documentation practices, and adherence to Emergent's procedures.
Duties and Responsibilities
  • Deviation and CAPA Management: Manage deviations and CAPAs to ensure root causes are identified and addressed.
  • Deviation Administration: Administer deviations through consultation, review, assessment, and participation in deviation investigations.
  • Root Cause Analysis: Conduct root cause analysis to identify the underlying causes of deviations.
  • Preparation of Deviation Summaries and System Reports: Prepare deviation summaries and system reports to ensure compliance with regulatory requirements.
  • Review and Approval of Deviations and CAPAs: Review and approve deviations and CAPAs to ensure compliance with regulatory requirements.
  • Quality Systems Reports and Improvement Projects: Provide technical expertise and advanced Quality Systems knowledge to support QA Management in ensuring the primary objective of manufacturing safe products.
  • Inspection/Audit Management: Participate in regulatory inspections and customer audits to ensure compliance with regulatory requirements.
  • Team Collaboration: Collaborate with cross-functional teams to ensure compliance with regulatory requirements.
Requirements
  • Education: Bachelor of Science in a related discipline.
  • Experience: Minimum of 5 years of experience in a related field.
  • Technical Knowledge: Advanced technical knowledge in a related scientific discipline, Quality Assurance, or Quality Systems.
  • Regulatory Knowledge: Broad and thorough technical and regulatory knowledge of current pharmaceutical analytical and manufacturing techniques/processes.
  • Communication Skills: Excellent written and verbal communication, influencing, and negotiation skills.

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