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Quality Document Control Associate

2 months ago

Windsor, Ontario, Canada BioVectra Inc. Full time
Quality Document Control Associate Job Description

Seeking a Quality Document Control Associate to support the MasterControl Document Management System and ensure compliance with GMP requirements.

About the Role

The successful candidate will be responsible for:

  • Supporting the MasterControl Document Management System (Document control, Document Formatting, etc)
  • Servicing 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
  • Additional duties assigned, based on business needs and the department supervisor's request
About the Ideal Candidate

The successful candidate should have:

  • 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
  • Ability to handle a variety of tasks simultaneously and prioritize work to meet deadlines
  • Ability to travel between sites on a frequent basis for training and support
  • Availability to support on weekends or evenings, if required
About BIOVECTRA

BIOVECTRA 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.

What We Offer

BIOVECTRA offers a competitive salary and benefit package.

Equal Opportunities Employer

BIOVECTRA is committed to creating an inclusive environment and building a team that represents a variety of backgrounds, perspectives, and skills.