Sr. Quality Assurance Auditor – Lab/Clinic

4 days ago

Toronto ON ML A, Canada Healwell AI Inc 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.

  • Quality Assurance Auditor

    2 weeks ago

    Toronto, Canada Think Research Full time

    **The Company** BioPharma Services Inc. is a subsidiary of Think Research. BioPharma Services was founded by two surgeons dedicated to advancing medical science to improve the life and spirit of their patients. With this same dedication and vision in mind, these physicians brought life to BioPharma. Through each success, and even some failures, the...

  • Senior Quality Assurance Auditor – Lab

    4 days ago

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

    Position SummaryThe 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...

  • Food Quality Assurance Auditor

    6 days ago

    Toronto, Canada Medina Quality Full time

    **Do you love to travel?** **Are you passionate about food safety and cross-cultural work?** **Do you have a strong belief in corporate social responsibility, diversity, and collaboration?** **If yes, Medina Quality is seeking charismatic, observant, self-disciplined and articulate applicants to join its audit team. Half the time you will be travelling...

  • Clinical Quality Auditor Lead

    2 weeks ago

    Toronto, Ontario, Canada Elevance Health Full time US$77,760 - US$134,136

    Anticipated End Date: Position Title:Clinical Quality Auditor LeadJob Description:Clinical Quality Auditor Lead*Must Have An Active Clinical License.Location: Virtual - This role enables associates to work virtually full-time, except for required in-person training sessions, providing maximum flexibility and autonomy. This approach promotes productivity,...

  • Quality Assurance Analyst

    2 weeks ago

    Toronto, Canada CAD Industries Ferroviaires Ltée Full time

    **Company Summary**: Cad Railway Industries Ltd. (CADRI) was founded in 1968 headquartered in Montreal. We take pride on being North America’s leader of full-service solutions in the freight, passenger and commuter rail industries in Canada, the United States and offshore. CADRI has other facilities in Calgary, Lethbridge (under the Caltrax banner) and has...

  • Quality Assurance Specialist

    6 days ago

    Toronto, Canada SickKids Full time

    **About SickKids**: Dedicated exclusively to children and their families, The Hospital for Sick Children (SickKids) is one of the largest and most respected paediatric healthcare centres in the world. As innovators in child health, we lead and partner to improve the health of children through the integration of healthcare, leading-edge research and...

  • Sr. Quality Assurance Technician

    2 days ago

    Toronto, Canada Give and Go Prepared Foods Full time

    Join to apply for the Sr. Quality Assurance Technician - Day role at Give and Go Prepared Foods. Give & Go Prepared Foods Corp. is a proud member of the Mondelēz family and a leading North American manufacturer of baked goods. Our Consumer Brands include the two-bite® brand, two bite-brownies®, Kimberley's Bakeshoppe™, Mason St. Bakehouse™, and The...

  • Sr. Quality Assurance Technician

    2 days ago

    Toronto, Canada Give and Go Prepared Foods Full time

    Join to apply for the Sr. Quality Assurance Technician - Day role at Give and Go Prepared Foods . Give & Go Prepared Foods Corp. is a proud member of the Mondelēz family and a leading North American manufacturer of baked goods. Our Consumer Brands include the two-bite® brand, two bite-brownies®, Kimberley's Bakeshoppe™, Mason St. Bakehouse™, and The...

  • Quality Assurance Specialist

    5 days ago

    Toronto, Canada NGARE EMPLOYMENT SOLUTIONS PTY LTD Full time

    Located in Barrie, Ontario, MediPharm Labs (TSX: LABS) offers a professional and collaborative workplace culture in a leading-edge facility built to international pharma standards. Our company is a recognized leader in the Cannabis industry, having received numerous entrepreneurship and cannabis awards. Our growing team of scientists, technicians, engineers...

  • Clinical Quality Assurance Coordinator

    2 weeks ago

    Toronto, Canada Lifemark Health Group Full time

    **Clinical Quality Assurance Coordinator** **Lifemark Health Group** **Location: Home Based Office within Ontario** **Are you a healthcare professional looking for a change?** Lifemark Health Group is seeking a healthcare professional to work as a **Quality Assurance Coordinator**. This is a remote position with potential for in-person meetings (within the...