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Quality Assurance Auditor - Jobs in Moncton, NB

BioVectra Inc.
Job LocationMoncton, NB
EducationNot Mentioned
SalaryNot Disclosed
IndustryNot Mentioned
Functional AreaNot Mentioned
Job TypeFull Time

Job Description

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 Auditor. This is a permanent, full-time position located in Charlottetown, PEI or Windsor, NS.The candidate will be responsible for:

  • Overseeing, managing and executing internal quality audits as defined per internal procedures across all sites.
  • Enhancing the Internal Audit program to ensure the most proactive steps are being taken to drive continuous improvement based on audit results
  • Developing comprehensive risk based internal audit plans based on:
    • Past internal audit results
    • QSR results/trends
    • Quality incident trends
    • Client audit findings
    • Regulatory audit findings
  • Proposing or implementing quality system changes resulting from changes to regulations applicable to BioVectras quality systems and operations (HC, FDA, EU, PMDA).
  • Tracking regulatory inspection trends.
  • Coordinating and executing all internal quality audits per internal procedures.
  • Traveling to all BIOVECTRA sites to execute scheduled internal audits for that site .
  • Assessing adequacy of BV SOP content against applicable regulations, client QAAs, and industry best practice.
  • Ensuring that findings are assessed holistically across the quality system and not only as isolated events.
  • Escalating major/critical findings to Senior Quality Management as required.
  • Compiling internal audit report findings, assigning and tracking corrective actions/follow-up actions to completion via the EQMS.
  • Resolving recommendations on the audit gap identified.
  • Ensuring audit finding classification consistency across all internal audits.
  • Ensuring audit task assignees completion of corrective action/follow-up tasks are completed on time.
  • Working to drive and participate in quality system-based changes to continuously improve the QMS.
  • Maintaining internal audit tracking tools and schedules to reflect current state (KPIs and audit readiness).
  • Participating in the migration of the Audit process in Master Control out of Unipoint.
  • Providing classroom training for internal auditing cross training as required.
  • Maintaining internal audit SOP in current state .
The successful candidate for this position should have:
  • Post-Secondary Education
  • Bachelors degree in a scientific field an asset
  • Quality Auditor certification considered an asset
  • Ten years of work experience with a pharmaceutical company
  • Five years directly in a Quality Unit auditing position
BIOVECTRA offers a competitive salary and benefit package. Interested candidates are asked to apply by choosing the "Apply Now" buttonClosing Date: February 18, 2022Date PostedFeb 1, 2022TypeFull-time - PermanentCareer LevelExperiencedCategoryManufacturingManagement and OperationsCompetition Number689Websitehttp://www.biovectra.com/RemoteCan Work RemotelyQuick Apply
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