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Quality Assurance Associate

In-person
Full-time
Experienced
Posted 7 days ago

BIOVECTRA has an opening for a Quality Assurance Associate. This is a permanent, full-time position located in Windsor, NS

The candidate will be responsible for:

  • 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.
  • 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.
  • Additional duties assigned, based on business needs and the department supervisor's request.

The successful candidate for this position should have:

  • Post-Secondary Education.
  • Bachelor's degree in a scientific field an asset.
  • Three years of work experience with a food or drug manufacturing company, with One-year direct experience in a Quality Unit position.

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

Closing Date: September 25, 2024

Competition Number: 6666
Company Website: http://www.biovectra.com/

About BioVectra Inc.

About BioVectra Inc.

BioVectra is a contract development and manufacturing organization (CDMO) that serves pharmaceutical and biotech companies with full-service cGMP outsourcing solutions for intermediates and active pharmaceutical ingredients (APIs). With over 45 years of experience, we are a reliable and innovative partner, specializing in:

  • Microbial Fermentation
  • Complex Chemistry
  • High Potency APIs
  • Biologics
  • Process & Analytical Development
  • Drug Development
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