Quality Assurance Associate

BioVectra Inc. has an opening for a Quality Assurance Associate. This is a permanent, full-time position located in Charlottetown, Prince Edward Island.

The candidate will be responsible for:

• Primary responsibility to provide timely review of analytical data, for analyses such as HPLC, GC and Karl Fischer.
• Supporting the incident programs (deviation, laboratory investigation, complaint, supplier etc), including reviewing, assessing the severity, and approving minor incidents and outcomes of Phase 1 OOS investigations and participating in the investigations of major incidents.
• Participating in the internal audit program and 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.
• Supporting the APR Program, Metrics and Scorecards Reporting Program, including QSR.
• Monitoring and enforcement of GMP requirements during day-to-day operations for all departments within the company.
• Supporting the supplier management program.
• 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.
• Issuing, checking, and archiving QC notebooks.
• Providing GMP and SOP training to various departments.
• Managing product label masters and creation.
• Supporting the CAPA program.
• Supporting Analytical validation and process transfer activities, and the overall method and Analytical process lifecycle by reviewing and approving analytical validation data and revising, reviewing and approving protocols, reports and work instructions as needed.
• Participating in the Pest Control program, including inspection and investigation.
• Performing batch record review and data review for release of critical raw materials, active pharmaceutical ingredients, and final products.
• Releasing critical raw materials, active pharmaceutical ingredients, and final products after successful completion of BioVectra batch release training.
• Supporting Process lifecycle by reviewing and approving creation and changes to batch records.
• Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes.

The successful candidate for this position should have:

• Post-Secondary Education.
• Familiarity with chromatographic analyses (HPLC/GC)
• Bachelor's degree in a scientific field an asset.
• Three years of work experience with a food or drug manufacturing company an asset.
• One year direct experience in a Quality Unit position.
• Proficient communicator, both written and oral.
• Able to work independently with minimal supervision as well as part of a team.
• Efficient at prioritization and scheduling.

BioVectra offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the "Apply Now" button below.

Starting/Entry Salary: $49,608

Closing Date: March 8, 2025