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Senior Quality Assurance Specialist (GCP Required)

June 3 2021
Industries Consulting services
Categories Production, Operations, Quality, Safety, Pharma, Biotech, Sciences, R&D, Pharma, Biotech, Quality assurance and control, Validation
Toronto, ON

QUALITY ASSURANCE SPECIALIST  [GCP REQUIRED]

Toronto, Ontario
Full Time

*Must have prior experience with ISO 9001 & GCP

ABOUT THE ROLE

Axiom Real-Time Metrics, Inc. is seeking a full-time Quality Assurance Specialist to join it's team. As a Quality Assurance Specialist, you will be working closely with the working closely with the Director of Quality Assurance and team members as required. This role must have prior experience with ISO 9001 & GCP.

KEY RESPONSIBILITIES

Core responsibilities will include:

  • Prepares key quality documentation (nonconformance reports, change controls, etc.).
  • Review quality and internal documentation (ie. GCP related documentation).
    • Assess clinical documentation to ensure completion of internal requirements.
  • Document quality assurance activities, such as internal audits.
    • Aid in performing tasks related to internal compliance audits.
    • Assist in the preparation of hosted audits.
  • Demonstrates a primary commitment to quality standards by maintaining compliance to the Quality Policy, internal procedures, GxP standards and all applicable regulatory requirements.​ 
    • Ensure ongoing abidance by industry regulatory and quality requirements.
  • Gather and organize statistical quality data.
    • Inspect data to detect areas for improvement.
  • Elaborate, recommend and oversee improvement actions.
  • Report on results of quality activities.
  • Detect coaching needs and take actions in accordance with these needs in order to ensure compliance with quality standards.
  • Execute risk management procedures.
  • Generate Standard Operation Procedures and Work Instructions, as required.
  • Ensure the maintenance of all controlled documentation, and other technical documentation.
  • Perform other related duties as assigned.

REQUIRED EXPERIENCE & EDUCATION

  • Bachelor's degree (BSc is preferred)
  • Certification (ie. Quality Auditor, Six Sigma, or Quality Improvement Associate)
  • 5 years – educational experience in clinical / pharmaceutical Quality Assurance  
  • Excellent oral, written communication, time management, and organizational skills
  • An excellent understanding of ISO:9001 and / or Quality Management Systems
  • Excellent knowledge of GCP and GDP
  • Proven to take initiative
  • Strong attention to detail 
  • Ability to work independently within a team environment
  • Long-term experience and working knowledge in QMS related documentation

APPLY FOR THIS POSITION

All interested applicants are requested to submit a resume and cover letter. We thank all applicants in advance for their interest but only those selected for interview process will be contacted.  No phone calls or third-party recruiters please.

Axiom is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, among other things, or status as a qualified individual with a disability.

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