Quality Assurance Specialist

6 days ago

Toronto, Ontario, Canada Trinity Consultants - Advent Engineering Full time
Job Summary

We are seeking a highly skilled Quality Assurance Specialist to join our team at Trinity Consultants - Advent Engineering. As a Quality Assurance Specialist, you will play a critical role in ensuring the quality and compliance of our clients' facilities and processes.

Key Responsibilities
  • Act as a liaison between the Facilities Department and onsite quality and regulatory groups to implement Corrective and Preventative Actions
  • Manage and participate in Facilities Department CAPA Program, ensuring all activities related to CAPAs are performed in a timely manner and in compliance with procedures and regulatory requirements
  • Monitor and track CAPAs assigned to the facilities department on a daily basis
  • Take ownership of CAPA requests and workflows in Computerized Maintenance Management System (BMRAM)
  • Attend weekly meetings to discuss CAPA progress and escalate obstacles, including presenting, taking notes, managing agenda items and invites
  • Conduct CAPA Effectiveness Checks, reviewing and analyzing relevant data and completing reports documenting findings
  • Provide support and training for Facilities personnel on regulatory and quality topics, such as proper documentation procedures and the use of QUMAS
Requirements
  • Well-developed communication skills, both verbal and written
  • Outstanding organizational skills, required to handle multiple projects concurrently
  • Strong data analysis skills, including proficiency in Excel and performance metrics
  • Strong GMP background, including working knowledge of preventative maintenance principles
  • Familiarity with a broad range of equipment used in pharmaceutical production, including bioreactors, chromatography skids, centrifuges/separators, air handlers, and HEPA
  • 12-month contract with high probability for extension
Qualifications
  • Bachelor's Degree/Undergraduate degree in Engineering, Biology, or equivalent
  • At least 5 years of related work experience in a QA or Compliance setting
About Us

Trinity Consultants - Advent Engineering is an engineering and consulting firm providing expertise to the pharmaceutical and biotechnology industries. We are committed to cultivating an authentic and diverse organization, welcoming all those interested in our work to apply. We are committed to providing an accessible and inclusive interview experience.

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