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Data Verification Specialist

2 months ago

Austin, Texas, United States ICU Medical Full time
Job Summary

The Data Verification Specialist will play a critical role in ensuring the Chemical Quality laboratory is in compliance with cGMP technical requirements. This position is responsible for providing independent data review of testing forms and batch records generated within the laboratory. The Specialist will also assist in the review and development of laboratory documents, including standard operating procedures (SOPs), and evaluation of new lab equipment and testing methodologies.

Key Responsibilities
  • Ensure cGMP compliance of electronic data
  • Perform independent data review of testing forms and batch records
  • Assist in instrument troubleshooting and maintenance
  • Support Operational Excellence (Lean / Six Sigma) activities and be accountable for sustainability and continued development in the work area
  • Provide input on opportunities and issues to management as necessary
Requirements
  • Thorough knowledge of various instruments, including HPLC and GC, and global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada)
  • Experience in a Quality Control role as a chemist or data verification in an FDA regulated environment
  • Strong technical and leadership skills, with good analytical and problem-solving skills
  • Ability to work effectively with all levels of individuals within the organization and have exhibited a high level of personal maturity and professional judgment
Work Environment

The Data Verification Specialist will work in an office and laboratory environment, with occasional movement and lifting of objects up to 25 pounds. Travel is typically less than 5% of the time.