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QA Associate

4 months ago

Toronto, Canada Apex Systems Full time

QA Associate (Document Review)


Apex Systems is a large staffing and consulting firm and we are looking for a QA Associates with experience with QA documentation review, exposure to GMP/GDP, and a background in life sciences for one of our biotech clients in Toronto.


Client: Biotechnology company

Contract/Perm & duration: 6-month contract (possibility of extension/conversion)

Location: Toronto

This position will be working 100% on-site as it is required for daily responsibilities


Responsibilities:

  • Reviewing executed batch records and equivalent production documents, as well as assisting in closure of batch record review backlog
  • Supporting day-to-day operations such as room release and reviewing manufacturing and equipment changeover activities
  • Reviewing quality events, including deviations, lab investigations, CAPAs, and change controls
  • Supporting document reviews, including but not limited to SOPs, COAs, protocols, and reports
  • Working closely with both Manufacturing, Quality Control, and Facilities teams in any quality matter
  • Responsible for performing quarterly walkabouts, following up on the observations, and supporting 5S excellence projects
  • Supporting various process improvement projects, contributing to the overall success of the GMP operations at MaRS7 and PMCRT-15 (Toronto GMP Sites


Key qualifications:

  • Undergrad or master’s degree in biological sciences, analytical chemistry, chemical engineering, biomolecular engineering, microbiology, or similar
  • 1-2 years experience in GMP industry (junior level)- Any experience in biotechnology industry is preferred but not required
  • Strong knowledge on GMP and GDP
  • Strong critical thinking skills when working on new procedures or process improvements
  • Strong teamwork and communication skills
  • Strong written and verbal communication skills and efficient in communicating to inter-disciplinary and cross-functional team
  • Detail-oriented individual with a passion for quality and a strong desire to contribute to a dynamic team
  • Proactive and able to work in a fast-paced team environment while prioritizing tasks for multiple projects
  • Familiar with electronic document and quality management systems (preferred but not required)