Senior Specialist, ISO Quality

Job Description

Reporting to the Vice President, Quality, we are looking for Senior Specialist ISO Quality who has experience in ISO 9001:2015. It is preferred the successful candidate will have demonstrated the ability to work in a laboratory setting in the life science field.

Key Responsibilities

  • Manage the ISO Quality System supporting Tube and Reagents and R&D Services. This includes, but is not limited to:
    • Maintaining the ISO Quality Manual and the supporting Quality System Standard Operating Procedures
    • Training personnel on the ISO Quality system and their responsibilities in executing ISO Quality processes.
    • Supporting the Deviation and CAPA process and approving Deviation Investigations and CAPA plans and completion
    • Support Non-Conforming Material Investigations and approve final Investigations and Material Disposition
    • Review and approve production records and approve product disposition
    • Providing input for and participating in Management Review
    • Keeping Risk Register up to date

Qualifications and Preferred Skills

  • B.S. preferred in Biochemistry, Chemistry, or a related field
  • 5-7+ years’ experience
  • Excellent written and oral communication skills
  • Cross-functional experience working across departments in an organization
  • Strong organizational skills with ability to work in a team and multi-task
  • Demonstrated Knowledge of the ISO Quality Standards and Processes
  • Demonstrated Communication and Collaboration skills to effectively provide training and coaching for ISO quality processes, update Management on key issues and risks.
  • Knowledge of the product to perform accurate quality assessments
  • Attention to detail 
  • Analysis, critical-thinking and problem-solving skills to review systems, find flaws and pose solutions
  • Experience with ETQ Reliance application a plus

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