Quality Assurance Specialist – ISI
Recruiting.com
full-time
Posted on:
Location Type: Remote
Location: Canada
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Salary
💰 CA$60,800 - CA$93,610 per year
About the role
- 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.
Requirements
- 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.
Benefits
- 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
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assuranceinternal auditsCAPA processSOP reviewsQuality SystemsGxP conceptsdata analysiscompliance monitoringprocess improvementdocument control
Soft Skills
effective communicationattention to detailinvestigative skillsproblem-solvingprioritizationadaptabilityinterpersonal skillsorganizational skillsdeadline managementcollaboration