Filament Health is looking for an enthusiastic individual with a keen eye for detail to fill the role of Quality Assurance Specialist with experience in the pharmaceutical industry. Reporting to the Quality Director, the ideal candidate will be a self-starter who needs minimal oversight and thrives in a dynamic work environment. They will provide quality support to ensure adherence to Good Documentation and Production Practices, Health Canada regulations as well as international jurisdictions such as the US, EU, UK and Australia.
About Filament Health Corp.
At Filament Health, we believe that naturally-derived psychedelic medicines can help treat the millions of people suffering from mental health conditions worldwide. Filament is an early stage pharmaceutical drug development company. We have developed technology which facilitates the production of stable, standardized formulations of any psychedelic species. These innovations have yielded patented methods to produce the world’s first pharmaceutical-grade, botanical psychedelic drug candidates that are being administered in clinical trials globally.
www.filament.health
Duties and Responsibilities
- Create, implement, and monitor GMP programs to ensure they are adequately followed and documented
- Ensure all documentation and processes and audit-ready; participate in third party audits
- Conduct internal bi-monthly audits (follow up to ensure corrective actions are completed as needed)
- Prepare CAPA reports and ensure actions are completed in a timely manner
- Ensure product release packages and shipping documents are organized
- Execute and track all GMP training of staff
- Conduct daily, weekly and monthly GMP checks and tasks
- Conduct shipping and receiving activities, including product shipments for Clinical trials and SAP
- Lead GMP meetings; encouraging a culture of accountability, inquiry and creative problem solving
- Manage the micro testing program including performing in-house micro testing
- Oversee all GMP document organization
- Assist production team with sample collection and sanitation activities
- Ensure all facility sanitation and equipment cleaning tasks are completed according to SOPs using approved chemicals
- Verify cleaning procedures and conduct environmental monitoring, as needed
- Review new equipment design and requirements and complete equipment commissioning plans
- Ensure Manufacturing Outlines are up to date and batch records are completed following established guidelines in the manufacturing outlines
- Assist with other tasks, as assigned by your supervisor
Qualifications
- Minimum of a B.Sc. in a science discipline or related diploma program.
- 2-4 years’ experience in Quality Assurance/Quality Control function
- Experience with Good Manufacturing Practices in pharmaceutical or similar discipline
- Knowledge of Health Canada Controlled Substances Act an asset
- Innovative mindset, collaborative team player, effective critical thinker, clear communicator (oral and written), and possess excellent problem-solving skills.
- Able to take direction and complete tasks with minimal supervision
Filament is an equal opportunity employer and values diversity. All employment is decided on the basis of qualifications, merit and business need. We thank all candidates for their interest in Filament; only those selected for an interview will be contacted.
Job Type: Full-time
Salary: $25.00-$32.00 per hour
Benefits:
- Casual dress
- Company events
- Dental care
- Extended health care
- Life insurance
- On-site parking
- Wellness program
Flexible Language Requirement:
Schedule:
Experience:
- Quality assurance: 2 years (preferred)
- Start-up: 1 year (preferred)
- Pharmaceutical manufacturing: 1 year (preferred)
Work Location: Hybrid remote in Burnaby, BC
Application deadline: 2023-09-25
