JOB SUMMARY

Regulatory and QA Assistant with strong communication skills and can perform various tasks to support the Quality Assurance Manager, the QA and Regulatory Assistant will effectively monitor and promote policies and programs in the day-to-day operations of the manufacturing site. Takes all necessary steps to ensure goods are handled and finished products are produced within prescribed quality specifications.

EXPERIENCE, EDUCATION & REQUIRED CERTIFICATIONS, LICENSES, OR DESIGNATIONS:

• Bachelor’s degree in chemistry, Biochemistry or related field
• 2-5 years of experience in QA/RA pharma, cosmetic or food manufacturing facility with direct experience regulatory compliance an asset
• Excellent documentation and/or record-keeping skills
• Strong attention to details is a must
• Good communication skills, both written and verbal
• Ability to work with minimal supervision and in a team environment
• Must have good interpersonal skills and demonstrated critical thinking
• Must be able to handle multiple tasks, prioritize assigned duties, and demonstrate flexibility
• Excellent computer skills: Microsoft Office suite and ERP system.

• Responsible for the full compliance of specific standards for product quality
• Investigate quality issues & customer complaints, implement corrective actions, and ensure continuous improvement.
• Responsible for the preparation and upkeeping of QA and regulatory documentations such as PSE, SDS, COA, Q&R, Ingredient List
• Prepare, review, and submit regulatory documents, including licenses, amendments, and renewals such as vegan, cosmos, organic, Leaping bunny etc.
• Compare third party analysis report such as GCMS for product approvals
• Monitor regulatory changes and update internal processes to maintain compliance.
• Manage records of regulatory submissions and correspondence.
• Support the coordination and implementation of regulatory strategies for new products, changes, and enhancements.
• Maintain comprehensive documentation for all QA/RA activities, including records of deviations, investigations, and corrective actions.
• Collaborate with production, R&D, and supply chain teams to ensure quality and regulatory compliance across all operations.
• Train and mentor employees on regulatory and quality standards.
• Upload documents to designated, secured online portals
• Carry out other activities needed essential to the effective operation of QA/QC/Regulatory department during the shift
• Support operations, sales, and CS activities on daily basis as per the business need
• Compliance with the Company’s Integrated Management Systems
• Conduct and document regular inspections, audits, and quality assessments to uphold Good Production Practices
• Compliance with the Company’s Quality, cGMP, Health, Safety, and Environmental requirements.
• Other duties as assigned