Bayshore HealthCare is looking for a Quality Assurance Associate and A-QPIC to support the implementation and maintenance of GxP Quality Systems and provide quality oversight for controlled and hazardous drugs. In this role, you will ensure compliance with Health Canada regulations, develop policies and procedures, and act as a backup QPIC for controlled substances.
What You'll Do
- Participate in the development, implementation and maintenance of the Quality Management System, Document Management System and Learning Management System.
- Ensure compliance with Health Canada requirements for controlled drugs under the Controlled Drugs and Substances Act (CDSA) and Narcotic Control Regulations, as well as Medical Device Establishment License (MDEL) requirements.
- Act as a back-up for the QPIC and maintain QA and A-QPIC oversight of processes for controlled drugs.
- Author and participate in the review and approval of SOPs related to controlled substances and Medical Device regulations.
- Oversee inventory reconciliation, discrepancy investigations and complete controlled drugs monthly Health Canada reporting.
- Perform security, access control and chain-of-custody measures for controlled drugs.
- Review batch records for compounded controlled drugs to ensure compliance.
- Lead investigations and CAPA for incidents involving controlled or hazardous drugs.
- Prepare for and support internal audits, spot audits and Health Canada inspections.
- Support quality oversight of hazardous and cytotoxic drugs, including safe handling and environmental controls.
- Ensure compliance with NIOSH and applicable provincial OHS requirements for hazardous drugs.
- Provide training and competency oversight for staff handling controlled or hazardous drugs.
- Conduct Policy, SOP and Work Instruction reviews and revisions, and participate in the development of new documents.
- Help ensure appropriate training assignments on rolled-out policies, procedures, and SOPs.
- Support management of Quality Events and deviations, conduct root cause analysis, and ensure effective CAPA.
- Assist with quality event trends analysis and resulting improvement initiatives.
- Identify training needs, participate in the development of training materials, and lead training sessions.
- Educate internal stakeholders on key quality deliverables and identify process improvements.
- Liaise with Quality leads from other business lines to collaborate on initiatives.
What We're Looking For
- A Bachelor’s degree in chemistry, biology or a health sciences field.
- An ASQ Quality certification, ISO Quality Management or Medical Devices or Auditor certification, or an equivalent Quality/Pharmaceutical Sciences/Regulatory certification.
- At least 5 years of experience in quality assurance, preferably in healthcare, medical devices or life sciences.
- Experience working under Health Canada’s CDSA and Narcotic Drug Regulations, including controlled drug handling, storage, and chain-of-custody processes.
- Proven experience conducting inventory reconciliation and resolving discrepancies involving controlled drugs.
- Experience in the development of policies, SOPs and Work instructions as per OCS and MDEL regulations.
- Previous experience working with Health Canada’s Medical Device Regulations (SOR/98-282) and HC-MDEL requirements for importers and distributors.
- Experience maintaining compliance with MDEL obligations such as complaint handling, incident reporting, recalls and record-keeping.
- Experience preparing for or supporting Health Canada MDEL & OCS inspections.
- Experience using quality systems like QMS, DMS, LMS, as well as ERP & CRM applications.
- Experience working with hazardous drugs under proper safety and containment guidelines.
- Strong interpersonal skills and ability to work independently and as part of a team.
- Proven ability to build consensus and lead new initiatives.
- High attention to detail for reconciliation and record accuracy.
- Demonstrated ability and competency in Microsoft LMS, DMS and QMS software.
- Exceptional organizational skills and ability to meet deadlines.
- Strong commitment to continual learning.
- Good analytical skills for investigating discrepancies.
- Ability to handle confidential and sensitive information responsibly.
- Ability to grasp the essence of issues, deal comfortably with ambiguity, and make high-quality decisions quickly.
Nice to Have
- A Master’s degree in a scientific discipline.
- Completion of Quality Management, Risk Management, or related courses.
Technical Stack
- Quality Management System (QMS)
- Document Management System (DMS)
- Learning Management System (LMS)
- ERP applications
- CRM applications
- Microsoft LMS, DMS and QMS software
Team & Environment
You will report to the Manager, Quality & Risk Management.
Work Mode
This is an onsite position.
