Quality & Regulatory Supervisor

Organika Health Products

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Who are we?

We are a premium natural health company from British Columbia, Canada, obsessed with helping people live healthier for over 30 years now!

As trendsetters in the health industry, we strongly believe everyone should have accessibility to natural wellness solutions. We are award-winning innovators, whose collective commitment is to offer the highest-quality standards and put our customers first.

Why work for Organika?

Working with us means you will belong to a team of driven individuals who thrive in a versatile and ever-changing environment. We are on a journey to achieve our vision of being the #1 guide for natural health in Canada and we are looking for individuals who are genuinely excited about this!

Certified as a Great place to Work® and a Diversity Equity Inclusion Workplace™ we are serious about providing an environment that supports happy, healthy, and hungry individuals achieve their personal and professional dreams. With over 70% of our team holding nationalities outside of Canada, and the ability to speak over 25 different languages, we are a team that welcomes everyone.

Aside from being a part of a globally recognized brand, there are some great benefits as well! Enjoy a bunch of OrganiPerks at your fingertips, including access to an on-site RHN, yoga, guided mediation, professional development allowance, fitness reimbursements, product discounts… just to name a few.

Want to know more about the role?

At our Head Office based in Richmond BC, this role will take responsibility for supporting the Quality and Regulatory groups to deliver on department and company objectives. This role will be responsible for:

  • Experience working with Product license Natural Product Number (NPN) application, notification, and amendment
  • Assist the Regulatory Manager to develop regulatory strategies and implement plan for the preparation and submission of regulatory documents.
  • Support the Regulatory group in the review of labels and specifications or as needed
  • Act as a back-up for the Regulatory Manager to ensure compliance with domestic and international regulations and standards
  • COA review for evaluation for new supplier assessments
  • Develop and maintain standard operating procedures or local working practices.
  • Coordinate sample test results from in-house and external labs to ensure that Raw Material (RM), and Finished Product (FP) are released in an efficient and timely manner
  • Work with key CMOs to ensure Quality and Regulatory standards are maintained in accordance with CFIA, Health Canada and FDA regulations
  • Maintain a current knowledge of applicable Safe Food for Canadians Regulations; Non-prescription and Natural Health Product Directorate (NNHPD) and the Food and Drug Administration (FDA) Dietary Supplement Regulations and maintain current knowledge of GMP/cGMP programs
  • Conduct analysis of suppliers and raw materials in order to expedite QC/QA releasing and reduce overall lab testing costs and associated fees
  • Assist with continuous improvement initiatives to improve quality systems, product quality and efficiency.
  • Train staff in regulatory policies or procedures.
  • Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes.
  • Review and approve COAs to ensure that product specifications have been met
  • Documentation requests from other departments
  • Analyze product complaint data to support customer service issues
  • Assist in regulatory tasks related to USA market such as FDA notification, FSVP registration, APHIS permits, Health Certificates, FDA facility registration, coordinating on custom duties / tariff ruling, claim substantiation files.
  • Assist with internal audits and inspections as needed
  • Participate and assist Senior QA/QC Manager when needed with mock recall and actual recall procedures
  • Perform general housekeeping of Quality office monthly
  • Perform other duties and tasks as assigned

Who would thrive in this position?

You are an innovative and hungry individual who has the humility to learn and develop alongside your team.

  • A level of education and experience equivalent to a bachelor’s degree in a scientific field (e.g. Biology, Chemistry) and a minimum of 5 year of experience of direct QA/RA experience in the GMP compliant pharmaceutical/biotech or food environment executing risk assessments and process improvements
  • Experience with the timely, accurate and efficient preparation and management of documents
  • Demonstrated ability to work effectively in a team environment with a strong multi-tasking propensity.
  • Strong attention to detail and organizational skills.
  • Strong problem-solving skills and communication skills (written and verbal).
  • Good analytical, mathematical, and computer skills (MS Excel, Word and Outlook).
  • Ability to work with minimal supervision.
  • Strong comfort level working across all organizational levels
  • Experience with Hazard Analysis and Critical Control Points (HACCP) is an asset
  • Good team player who values aligns with the mission and vision of Organika Health Products Inc
  • Proactive and results driven; ability to work with a sense of urgency

If this sounds like a journey you want to be a part of, reach out!

#livingthedream #dreamjob #lovewhatyoudo #loveyourwork

Job Type: Full-time

Schedule:

  • Monday to Friday

Work Location: One location

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