Quality Assurance Specialist

at  Micrylium Laboratories Inc

OVERVIEW

The QA Specialist will be technically qualified to assist the Head Chemist in the laboratory with testing and record keeping. As a member of the QA/QC team, they will review and help assist the production crew with batching and receiving of materials in accordance with GMP standards. This individual must have good written and verbal communication skills to liaise with all regulatory bodies including Health Canada, FDA and EPA

EDUCATION:

• Bachelor’s degree in a science field (chemistry or microbiology preferred)
• Post graduate diploma or certificate in Pharmaceutical Quality Assurance and Quality Control & Regulatory Affairs
• 2 years of experience in Quality Assurance in pharmaceutical or related industry
• Excellent Written & Spoken English
• Computer skills including MS Office
• Employment history demonstrating a high degree of trust
• Polite and able to work as a team
• French and/or other Languages Communication and Reporting
  Job Types: Full-time, Permanent
  Pay: $42,000.00-$55,000.00 per year

Schedule:

• Monday to Friday

Work Location: In person
Expected start date: 2025-02-1

• Maintain ISO 9001 & 13485 accreditation and support the continuous improvement of the QMS policies and procedures
• Manage an interactive CAPA process to ensure appropriate root cause analysis, follow up actions and documentation
• Ensure internal ISO audits are completed on a routine basis
• Conduct internal and external audits, compliance gap analysis against GMP and ISO requirements
• Ensure and assist on the maintenance of the Quality Records, including but not limited to Quality related: OOS, NC, CAPA, customer complaints, change controls, calibration records, incoming raw material evaluation of operations: BPR records, training records, work instructions, cleaning and sanitation records, production plan of equipment, maintenance plan and records of projects, validation plans and records
• Review and release raw materials, packaging materials and finished goods
• Train staff on SOPs, GMP, ISO, WHIMIS
• Verify new suppliers and complete the annual performance review for the existing suppliers
• Prepare a weekly report for the President
• Report all Health & Safety Issues to management
  Join us as we strive for excellence in our products through rigorous quality assurance practices!