Quality Assurance Specialist

Organika Health Products IncVancouver, BC

About The Position

We are looking for an experienced Quality Assurance Specialist to support the Quality team in delivering on department and company objectives related to product quality and regulatory compliance.

Requirements

  • Bachelor’s degree in a scientific discipline (e.g., Biology, Chemistry) plus a minimum of 6 years’ direct Quality Assurance experience in GMP-compliant pharmaceutical, biotech, or food environments
  • In-depth understanding of Health Canada regulations for Natural Health Products and Food Safety regulations
  • Proven ability to prepare and manage documentation accurately and efficiently.
  • Strong teamwork skills with the ability to manage multiple tasks simultaneously.
  • Exceptional attention to detail and organizational skills.
  • Excellent problem-solving and communication skills, both written and verbal.
  • Proficient in using AI tools to analyze data and develop new processes and efficiencies within the department.
  • Competent with Microsoft Excel, Word, Outlook and Asana.
  • Ability to work independently with minimal supervision.
  • Comfortable engaging with stakeholders across all organizational levels.

Nice To Haves

  • Experience with Hazard Analysis and Critical Control Points (HACCP) is an asset.
  • Alignment with Organika’s mission and values; proactive, results-driven with a strong sense of urgency.
  • Six Sigma or Lean certification is considered an asset

Responsibilities

  • Review and approve Manufacturing Records to ensure materials are released efficiently and on schedule.
  • Ability to interpret and apply technical documents such as SOPs, batch records, and regulatory submissions
  • Maintain continuous compliance with the company’s Food Safety Program by coordinating updates and follow-ups with the Senior QA/QC Manager.
  • Assist the Senior QA/QC Manager in executing mock recalls and actual recall procedures.
  • Evaluate Certificates of Analysis (COAs) during new supplier assessments and for product release decisions.
  • Develop, update, and maintain Standard Operating Procedures (SOPs) and local work practices.
  • Coordinate and review sample test results from internal and external laboratories to ensure timely release of Raw Materials and Finished Products.
  • Collaborate with Contract Manufacturing Organizations (CMOs) to ensure adherence to CFIA, Health Canada, FDA, and GMP/cGMP regulatory standards.
  • Stay current on regulations including Safe Food for Canadians, NNHPD, FDA Dietary Supplement regulations, and GMP/cGMP guidelines.
  • Analyze supplier and raw material data to expedite QA/QC release processes and reduce lab testing costs.
  • Lead and contribute to continuous improvement initiatives aimed at enhancing quality systems, product quality, and operational efficiency.
  • Train staff on relevant regulatory standards and procedures.
  • Monitor industry and regulatory trends to assess potential impacts on organizational processes.
  • Respond to documentation requests from other departments promptly.
  • Analyze product complaint data to support customer service resolution efforts.
  • Assist with internal audits and regulatory inspections as required.
  • Maintain the Quality office’s cleanliness and organization monthly.
  • Experience working with contract manufacturers and suppliers globally
  • Willingness to travel occasionally if required for supplier audits or site visits
  • Experience in Developing and Reviewing Product Specifications

Benefits

  • access to an on-site RHN, yoga, guided mediation, professional development allowance, fitness reimbursements, mat-leave top-up, regular social events, product discounts
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