Quality Assurance Associate
BioVectra
Windsor, NS, Canada
2d ago

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

The candidate will be responsible for :

  • Reviewing and approving documents required to ensure the QC and Analytical department are in compliance with good laboratory procedures
  • Reviewing and approving new and revised batch products records (BPRs) to ensure processes are in compliance with Good Manufacturing Practices (GMP)
  • Performing facility evaluations as part of general compliance activities, and performing inspection and QA approval of manufacturing suites
  • Preparing audit checklists and documenting audit findings in accordance with corporate procedures
  • Performing review of cleaning validation and verification data to support process activities
  • Completing analytical review of critical raw materials to confirm disposition prior to distribution for use
  • Performing process and analytical data review for the final release approval or rejection of GMP products destined for pharmaceutical use
  • Reviewing all process and quality events (deviations, OOS, and CAPA) associated with the release of a final product batch
  • Providing technical assistance / reviews and approvals on equipment and process validations programs
  • Assisting and preparing mock process inspections prior to FDA and Health Canada audits
  • Participating in customer audits, including providing document support, discussion, and response to observations
  • Collecting water samples from HP water systems and air / surface samples from rated processing suites to support our environmental monitoring program
  • Remaining current with all applicable GMP, FDA, Health Canada regulations and ICH guidelines related to the manufacture, testing and distribution of BioVectra products
  • The successful candidate for this position should have :

  • Bachelors of Science plus minimum 2 years of experience in a GMP environment
  • Bachelors of Science in Biochemistry or Biology preferred
  • Knowledge of Equipment and Controls Commissioning and Qualification
  • Experience with Quality Assurance, Process & Cleaning Validation,
  • Knowledge of cGMP, Health Canada regulations and FDA guidelines
  • Good oral and written communication skills
  • Ability to work independently with minimal supervision
  • Apply
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