About the role

Quality Assurance Specialist ensuring compliance with health regulations and internal requirements at Cencora. Conducting audits and supporting quality management systems for healthcare and pharmaceutical services.

Responsibilities

Implement quality assurance procedures as per regulatory (Health Canada and any federal or provincial authorities), client, and internal requirements
Complete required volume of internal audits as outlined in the QA audit calendar based on risk, which may include: PSPs, PV, Nursing & Clinics, Pharmacies
Organize and conduct internal audits for each assigned area, internal process/system, and/or department to ensure regulatory and client requirements are implemented and met
Analyze and evaluate available data (e.g., Patient files, PIRs, SOP/WIs, PV records etc.) to monitor compliance and prepare written audit reports of findings and observations
Support ISI teams with QMS requirements including document control, training, issue review/CAPAs
Participate in new PSP Launch Projects as assigned, including ensuring all QA requirements are fulfilled
Manage controlled documents request, review and issuance workflow
Keep QA management up-to-date on findings and status of corrective/preventive actions
Co-manage the CAPA process by recording, tracking, and evaluating non-conformances/issues and CAPA reports
Identify, monitor, and present trends to management team
Implement and/or support continual process improvement related to ISI processes and/or internal processes
Assist QA Management during audits by sponsors/clients and/or regulatory agencies
Maintain organization of internal and external audit files and the archiving of QA documents.

Post-secondary education in a related discipline
Minimum of 3-5 years’ experience in a quality assurance role in healthcare, pharmaceutical, or biotechnology industry (or similar)
Experience with Quality audits a must
Practical knowledge of the healthcare products industry
Familiar with GxP concepts from Health Canada or other regulatory bodies
Extensive experience in internal and external audits, CAPAs, SOP reviews
Understanding of Quality Systems (eQMS experience is an asset)
Ability to communicate effectively both orally and in writing
Bilingualism, French/English is required for positions located at the VSL, QC office, and an asset for other sites
Strong attention to detail
Strong investigative and listening skills
Excellent problem-solving skills
Ability to prioritize and seek support as required
Adaptable to change and to learn new skills as required
Effective interpersonal skills with the ability to collaborate with management team and all key internal and external customers
Effective organizational skills
Ability to consistently meet deadlines
Knowledge of Microsoft Power Point with demonstrated presentation skills
Knowledge of Microsoft Word, Excel, and other Office Programs
Comfort working with electronic systems.

Support for working families, including backup dependent care
Adoption assistance
Infertility coverage
Family building support
Behavioral health solutions
Paid parental leave
Paid caregiver leave
Training programs
Professional development resources
Opportunities to participate in mentorship programs, employee resource groups, volunteer activities