Senior Compliance Specialist
5 days ago
The Opportunity
We are seeking a detail-oriented individual to join our quality team as a Senior Compliance Specialist - Quality Assurance. This role will involve working closely with various departments to ensure compliance with Health Canada regulations and guidelines.
Responsibilities:
- Training new Quality Assurance team members on CMO procedures
- Collaborating with Quality Control, Regulatory Affairs, Operations, and Marketing departments
- Leading review and enforcement of Canadian and EU cGMP
- Revising and creating Standard Operating Procedures aligning to CMO initiatives
- Tracking and trending lot release and KPI data
- Communicating with managers and teams
- Compiling and reviewing CMO lot release reports
- Reviewing CMO Transfer documents
- Participating in internal and external audits
- Working collaboratively with manufacturing teams
- Supporting continuous improvement projects
Experience:
- Degree or diploma in biology, biotechnology, pharmacology, or related field (or equivalent working experience)
- Working knowledge of Good Documentation Practices, Good Manufacturing Practices, and Cannabis Regulations
- Experience reviewing and revising regulated documents
- Experience working in an ISO:9001 or GMP environment
- Experience in fast-paced environments requiring time management, organization, and problem-solving skills
- Working knowledge of Microsoft Office suite of programs
- Experience with ERP systems (Sage or SAP)
- Strong verbal and written communication skills
Salary Range: $80,000 - $110,000 per year, depending on experience
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