Senior Quality Assurance Associate

at  BioVectra Inc

BIOVECTRA Inc. is a leading bio-science business in Prince Edward Island and Nova Scotia, focused on contract manufacturing and product development of active pharmaceutical ingredients, pharmaceutical intermediates, and bioreagents.
BIOVECTRA has an opening for Senior Quality Assurance Associate. This is a permanent, full-time position located in Windsor, NS.

• Leading cross functional investigations to support product release
• Participating in the internal audit program and leading/supporting external audit requirements.
• Managing and leading changes to SOPs and supporting changes to SOPs made by other departments through the change control review process.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.
• Inspecting and releasing rooms and performing facility inspections as part of general compliance activities.
• Preparing or assisting in the preparation of reports and protocols, including validation and qualification.
• Providing GMP and SOP training to various departments.
• Supporting Process lifecycle by reviewing and approving creation and changes to batch production records.
• Additional duties assigned, based on business needs and the department supervisor’s request.
• Supporting the establishment of CAPA plans and determine their effectiveness