Senior Qa Operations Specialist

Maravai LifeSciences

Jupiter, FL, United States
On-site
Quality management system maintenance
Quality events review and approval
Change control review and approval
Maravai LifeSciences is seeking a Senior QA Operations Specialist to enhance their Quality Assurance team in Jupiter, FL. The role involves managing the Quality Management System, conducting quality investigations, and ensuring compliance with industry standards

Job Summary

  • Lead the maintenance and continuous improvement of the Quality Management System, review and approve product and new product development documentation, and track and report on key quality metrics.
  • Responsible for reviewing and approving Quality Events (e.g. deviations, non-conformances, OOS, CAPAs, and complaints) to ensure appropriate investigations are thorough and completed in a timely manner.
  • Leads the audit program, including conducting internal audits and hosting external or third-party quality audits (e.g. customers, ISO, etc.).

Matching Summary

Match Score: 85

Maravai LifeSciences is seeking a Senior QA Operations Specialist to enhance their Quality Assurance team in Jupiter, FL. The role involves managing the Quality Management System, conducting quality investigations, and ensuring compliance with industry standards.

Skills & Requirements

Must-have

  • Quality Management System maintenance
  • Quality Events review and approval
  • Change control review and approval
  • Document and record control
  • Quality investigations and root cause analysis
  • Risk identification and mitigation
  • Internal and external audit leadership
  • Supplier quality support

Nice-to-have

  • Continuous improvement initiatives
  • Cross-functional team leadership
  • Training program oversight
  • Customer interfacing skills

Key Requirements

  • Bachelor's Degree in scientific discipline
  • 5 years relevant experience in life science industry
  • Knowledge of ISO 13485 standards
  • Proficient in root cause analysis tools
  • Proficient in Microsoft Office

Work Rights

Not specified

Tailored Resume

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