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Quality Assurance Associate

2 months ago

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

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.

We are seeking a Quality Assurance Associate to join our team in Windsor, NS. This is a permanent full-time position that requires a strong understanding of quality management systems and document control.

Key Responsibilities
  • Support the MasterControl Document Management System (Document control, Document Formatting, etc)
  • Servicing the document control email mailboxes by responding to user queries in a timely manner
  • Issuance and archival of Production Batch Records
  • Creation and issuance of Product Labels
  • Archival, retention and disposal of Quality Management Records
  • Participating in the internal audit program and supporting external audit requirements
  • Monitoring and enforcement of GMP requirements during day-to-day operations within the department
  • Prioritizing and timely completion of tasks to meet and exceed Key Performance Indicators
  • Timely escalation of problems and issues to their supervisor to prevent any delays and risk compliance
  • Preparing or assisting in the preparation of data and reports for KPIs
  • Participating in document lifecycle activities of SOPs, and QA review and approval of SOP changes
  • Adhering to BioVectra's Health and Safety Policy as outlined in CP0010 Occupational Health and Safety Policy, Statements of Principle, and Responsibilities
Requirements
  • Post-Secondary Education
  • One-year direct experience in a Quality Unit position
  • Working knowledge of MS office tools such as Word, Excel, Outlook
  • Three years of work experience in a similar role in a food or drug manufacturing company is an asset
  • Strong written and oral communications skills are necessary, as this position requires interaction with various levels of management, as well as interaction with external technical support teams
  • Candidate must be able to handle a variety of tasks simultaneously and must be able to prioritize work to meet deadlines
  • Candidate must be prepared to travel between NS and PE sites on a frequent basis for training and support
  • Candidate must be available to support on weekends or evenings, if required

BioVectra offers a competitive salary and benefit package. We are an equal opportunities employer and welcome applications from diverse candidates.