07 Nov
|
Fertin Canada
|
Langley
07 Nov
Fertin Canada
Langley
Job Summary
The Quality Assurance & Regulatory Affairs Specialist (Alternate Quality Assurance Person - AQAP) is responsible for managing all quality assurance processes within the company, ensuring adherence to internal standards and regulatory bodies. Reporting to the Manager, Quality Assurance, this is a crucial role in maintaining high standards of product quality and regulatory compliance. This role will also support the nutraceutical/food quality assurance function of the organization.
Responsibilities:
· Quality Assurance & Regulatory Affairs: Implement and maintain quality standards and related to ensure compliance with regulatory bodies (Health Canada, FDA), and other relevant certifications and licenses. Maintain comprehensive documentation for quality processes, including but not limited to HACCP, ERP system, change control, artwork review and MMR review as required.
· Licenses – Apply, Maintain and update all applicable licenses
· HACCP Program – Effective management of HACCP program
· ERP System – Support in implementation and training on new ERP system
· Change Control - Effective Management of Change controls.
· Document Control and Record Keeping: Maintain and secure technical documents, ensuring they are current and controlled as per GMP. Establish, maintain and enforce SOPs, record-keeping systems, ensuring proper documentation practices.
· Inspection Standards: Implement standards for inspecting, testing, and evaluating product as per quality and regulatory standard.
· Specification Compliance:
Ensure compliance with in-house and external specifications and standards.
· Audits: Help Performing internal audits and vendor evaluation audits to determine quality qualifications. Actively participate in external audits by regulatory and/or certification bodies as well as customer audits
Other Duties: Support organizational tasks assigned by Manager, Quality Assurance.
Requirements:
· Education: Minimum Bachelor's Degree in Biological Sciences, Pharmacy, Food, or a post-secondary diploma in a science-related technical discipline.
· Certification: quality or regulatory certification considered an asset.
· Experience: Minimum of 4+ years of experience in Quality Assurance. Experience in the nutraceuticals industry preferred; food safety and/or pharmaceutical experience considered an asset.
· Quality Accreditation: Experience with GMP, ISO, or any other quality accreditation.
· Ability to research, analyze, and report independently across a breadth of topics.
· Excellent administrative and people skills.
· Ability to work under pressure.
· Flexibility to adjust course when required.
· Ability to work autonomously and prioritize workflow.
· Flexible approach to working hours when needed.
Pay: $53,000.00-$63,000.00 per year
Benefits:
- Casual dress
- Company events
- Company pension
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Versatile schedule
- Life insurance
- On-site parking
- Paid time off
- Vision care
Work Location: In person
📌 QA & RA Specialist (Langley)
🏢 Fertin Canada
📍 Langley