Senior Quality Assurance Auditor – Lab

6 days ago

Toronto, Ontario, Canada HEALWELL AI (TSX: AIDX) Full time

Position Summary
The Senior Quality Assurance Auditor is responsible for ensuring that the quality assurance audits are planned, conducted, and reported as scheduled. The Senior QA Auditor supports QA Management in promoting and assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs. This position directly reports to the Senior Director, Global Quality Assurance.

Duties And Responsibilities

  • Performs inspections of Bioanalytical GLP and Non-GLP studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies including Study Plans, In-process audits, Raw Data Audits and Analytical Report Audits and reports the observations of such inspections to the Principal Investigator(s) and Laboratory Management.
  • Performs audits of Method Validation activities including in-process audits, raw data reviews and Validation Report.
  • Conducts various facility, process and system audits, including audits of equipment maintenance, training records, archiving processes and computer validation and reports the observations of such inspections to the Laboratory Management.
  • Performs audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMA, etc.) including pre-study documentation , in-process activities, end-of-study documentation and clinical study reports, protocol and ICF review.
  • General Quality Assurance Statements for Analytical Reports, and Clinical Study Reports as per Standard Operating Procedures.
  • Performs Vendor Qualification Audits.
  • Keeps Management up to date with findings and follow up on corrective actions.
  • Complete CTA applications and communicate with TPD as required.
  • Assists in the review, control and distribution of SOPs.
  • Assists QA management in hosting sponsor and regulatory audits/inspections.
  • Trains other QA staff on tasks/activities specified by QA management.
  • Assists QA management in the training of BPSI staff on SOPs, GCP, GLP, etc.
  • Coordinates and interacts with other departments to ensure corporate, departmental and project goals are met.
  • Performs other relevant tasks delegated by QA management.

Qualifications

  • University degree in a scientific area, or equivalent.
  • Minimum 4 years QA experience, preferably including audits of Phase 1 and /or BA/BE studies
  • Excellent working knowledge of Principles of GLP, ICH guidelines, OECD, GCP, FDA regulations and guidelines, HPFB guidelines and Canadian Food and Drugs Act.
  • Experience writing and reviewing Standard Operating Procedures (SOPs).
  • Excellent organization, multi-tasking, communication and interpersonal skills.

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