CMO Quality Assurance Specialist - Lot Release (Contract)

The Opportunity

We are looking for a very well organized and detail-oriented individual to join our quality team. If you have sound judgment, great time management skills mixed with the ability to work as part of an ever-growing team, we want to hear from you!

Responsibilities

Training new Quality Assurance team members on CMO procedures.

Collaborate with Quality Control, Regulatory Affairs, Operations, and Marketing departments to ensure compliance with Health Canada regulations and guidelines.

Lead review and enforcement to Canadian and EU cGMP.

Revise and create Standard Operating Procedures that align to CMO initiatives according to the Change Control procedure in the Quality Management System.

Tracking and trending lot release and KPI data.

Communicating between their manager and the rest of their team.

Compiling and reviewing CMO lot release reports.

Reviewing CMO Transfer documents.

Participating in internal and external audits when required.

Working collaboratively with members of the Manufacturing to improve processes and optimize productivity. Ensuring timely response to potential lot release impact with corrections and their timelines.

Supporting continuous improvement projects.

Other duties assigned.

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 as asset

Experience reviewing and revising regulated documents

Experience working in an ISO : 9001 or GMP environment considered an asset

Experience in a fast-paced working environment where time management, organization and problem solving were key skills

Working knowledge of Microsoft Office suite of programs

Experience with ERP systems (Sage or SAP) considered an asset

Strong verbal and written communication skills