Quality Assurance

Job description:

About Us:

CanPrev Natural Health is a dynamic and innovative company dedicated to creating exceptional products in the natural health industry. Born from a passion to make natural medicine safe, effective, and accessible to everyone, we've been empowering Canadians to take charge of their health for over two decades.

Our team is driven by innovation, collaboration, and a shared commitment to helping people live healthier, more vibrant lives.

Position Overview:

The Quality Assurance (QA) Lead/Coordinator will play a significant role leading and coordinating day to day quality activities at CanPrev site. The position is largely responsible for document creation, compliance management, and GMP implementation with the collaboration of internal teams and other stakeholders in the facility. The ideal candidate will be results-driven and self-starter with experience in quality management systems.

Key Responsibilities:

• Lead and guide QA/QC team on daily QA/QC activities and responsibilities.
• Develop and update finished product specifications (FPS) in coordination with the Product Development team.
• Perform risk analysis of product and process to create risk assessment matrix.
• Identify training needs for relevant employees and manage employee training matrix.
• Perform quality activities including monitoring, trend analysis, and identifying opportunities for improvement.
• Perform annual or quarterly internal audit including audit report, and non-conformance follow up. Provide support for external audit and regulatory inspection.
• Draft SOP/form/work instructions as required.
• Maintain NHPR GMP compliance at Canprev site.
• Ensure quality team adherence to NHP GMP guidance documents and good documentation practice.
• Develop, maintain, and update finished product specifications (FPS) in coordination with the Product Development team. Includes identifying test specifications, limits and methods as per Health Canada's Quality of Natural Health Guide, USP and other acceptable pharmacopoeias.
• Lead and oversee our real-time stability program by developing protocols, managing sample pulls and testing, evaluating data and generating reports to ensure compliance with regulatory requirements and shelf-life claims.
• Review NHP Batch records to ensure compliance as per finished product specifications (FPS).
• Create, review, and finalize finished product certificate of analysis (CoA).
• Review change control requests, assess downstream effects and provide recommendations for the change with appropriate record keeping.
• Coordinate, implement, and track planned and unplanned deviation with contract manufacturers and CanPrev internal Operations team.
• Conduct root cause investigation for quality issues; investigate and document Out of Specification (OOS) cases and assign, implement and monitor the appropriate corrective and preventive action (CAPA).
• Review and address customer feedback and reportable events or recalls.
• Lead design, perform and report writing of stability study protocol and report writing
• Natural Health Product (NHP) testing specification, limit and method
• Review new suppliers for approval and conduct performance evaluation of existing suppliers and co-manufacturers.
• Provide input and manage quality activities in eQMS software.
• Assist in CanPrev NHP site licence renewal and addressing observations.
• Perform other duties as assigned.

Key Skills

• QMS and manufacturing software familiarity
• Proficiency on google drive and associated application (Google doc, sheet, etc)
• Collaborative and cooperative mindset
• Ability to work independently or with minimum supervision
• Quality certification/degree is an asset
• Working experience in NHP GMP settings is an advantage
• Working experience with eQMS software is an advantage

Key Qualifications

• Bachelor's degree in quality assurance, life science, food science, scientific or technical field with a strong foundation in Natural Health Product safety and quality management systems.
• 5+ years of experience in quality in NHP, food or pharmaceutical manufacturing environment.
• Solid understanding on GMP requirements of SOR 2003: 196, Natural Health Product Regulations (NHPR), 21 CFR part 111: cGMP Dietary Supplement.

Schedule

• Monday to Friday, Hybrid - 3 days onsite, 2 days remote.
• Location: Scarborough, ON M1S 3R5

Job Types:
Full-time, Permanent

Pay:
 CA$65, CA$70,000.00 per year

Benefits:

• Dental care
• Flexible schedule
• Paid time off
• Store discount
• Vision care

Why Join Us

• Collaborate with a passionate, purpose-driven team in the health and wellness space.
• Be part of a growing organization making a meaningful impact on people's lives.
• Competitive compensation and comprehensive benefits package.

How to Apply:

Please submit your resume and a cover letter outlining your qualifications and explaining why you are the perfect fit.