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Quality Assurance Specialist

2 months ago

Windsor, Ontario, Canada BioVectra Inc. Full time
Quality Assurance Specialist

BioVectra Inc. is a leading contract drug manufacturing organization (CDMO) that supports top pharmaceutical and biotech companies worldwide. We are passionate about improving patient care by making better therapeutics.

We are seeking a Quality Assurance Specialist to join our team in Windsor, Nova Scotia. This is a 12-month term position based out of our facility.

The Role

You will be responsible for supporting our Quality Unit teams, including document control, quality electronic systems, quality system programs such as change control and supplier management, and batch review. You will identify and correct deficiencies within our Quality Management System.

  • Key Responsibilities:
  • Performing GMP batch record and data review as per assignment and training for release of products.
  • Identifying, acknowledging, and escalating deviations and other quality system incidents as needed, and assisting in incident resolution.
  • Scanning BPRs for archive and retrieving files to support audit and client requests.
  • Supporting the documentation archive program.
  • Issuing QA controlled documents for activities supporting GMP production.
  • Supporting quality system programs including change control, incidents, supplier management, and client requests.
  • Assembling data tables in support of PVR/APR for new projects.
  • Supporting the CAPA program.
  • Providing support for daily administration of quality electronic systems and participating in related project plans.
  • Reviewing and initiating revisions to SOPs.
  • Participating in the Facility Inspection Program.
  • Inspecting and approving manufacturing suites for use.
  • Participating in internal and external audits.
Requirements

To be successful in this role, you will need:

  • Ability to work with minimal supervision in a multi-task team environment.
  • High attention to detail, excellent decision-making, and problem-solving skills.
  • Excellent oral and written communication skills.
  • Post-secondary education is required. A bachelor's degree in a scientific field is an asset.
About Us

BioVectra Inc. is a contract drug manufacturing organization that values teamwork, respect, professionalism, and quality. We strive to offer a welcoming and inclusive environment that promotes diversity and excellence.