Quality Assurance Associate

The Quality Assurance Associate is responsible for supporting the implementation, execution and maintenance of quality systems and programs. The QA Associate will ensure continuous compliance with Canadian, US and European quality compliance regulations and requirements.

General Duties:

• Maintain an in-depth knowledge and understanding of current GMP, including GUI-0036 and GUI-0001.
• Act as a catalyst for change and improvement in performance and quality.
• Ensure all GMP related activities are performed in compliance with regulatory requirements and industry standards.

Role specific Duties:

• Serves as quality representative to perform the quality review and/or provides quality approval of DCCs, Deviation reports, Laboratory investigations, CAPAs, Change controls, memorandums, and any other quality related document.
• Oversee and, as necessary verify, processes that impact generation of data (e.g.: calibration and maintenance of lab equipment).
• Review and approve of incoming laboratory samples and manufacturing starting materials.
• Review and approve of Environmental Monitoring (EM) data.
• Review and approve of water sampling data.
• Redact and/or review and approve Standard Operating Procedures (SOPs).
• Maintain quality related files and databases up to date.
• Review and approve executed Batch Production Records.
• Review and approve validation protocols.
• Review and approve Laboratory Data Record Files.
• Review and approve stability plans.
• Review and approve materials and product specifications.
• Review and approve certificate of analyses.
• Participate in self-inspection activities.
• Participate in external audit activities.
• Perform vendor assessment and qualification.
• Integrates risk management principles into the company processes and workflows.
• Integrates LEAN management principles into the company processes and workflows.
• Generates Key Performance Indicators.
• Write meeting minutes as needed.
• Participate in any activity related to continuous improvement of the company processes.
• Perform other quality related tasks, as needed.
  

Skills:

• Performance oriented.
• Details oriented.
• Adherence to defined timelines.
• Organization skills.
• Negotiation and influential skills.
• Interpersonal skills.
• Any certification in LEAN (e.g., 6 sigma Green belt) would be an asset.
• Any certification in Quality Risk management would be an asset.
  

ACKNOWLEDGEMENT AND AGREEMENT

Education and Experience Requirements:

• M.Sc or equivalent in Bioprocessing related field such as Biology, Biotechnology, Biochemistry or equivalent and 2+ years pharmaceutical work experience.
• B.Sc or equivalent in Bioprocessing related field such as Biology, Biotechnology, Biochemistry or equivalent and 3+ years pharmaceutical work experience.
• At least 2 years of relevant experience in a Quality control role or equivalent in a pharmaceutical facility.
• Experience in the implementation or enforcement of HC GUI-0036 requirements.
• Experience in the implementation or enforcement of HC GUI-0001 requirements.
• Experience with the USFDA CFR part 210 & 211, CFR part 820 would be an asset.
• Experience with the ICH guidelines would be an asset.