Data Verification Specialist

ICU Medical • Austin, TX

3d

About The Position

The Data Verification Specialist ensures the Chemical Quality (CQ) laboratory complies with cGMP technical requirements, including training, data review, pre- and post-sterile product testing, investigational testing and investigations, and area-related projects. The role independently reviews testing forms and batch records generated within applicable laboratories. The Specialist may also assist with reviewing and developing laboratory documents such as standard operating procedures (SOPs), evaluating and installing new laboratory equipment, and introducing new testing methodologies.

Requirements

• Be at least 18 years of age.
• Bachelor’s degree in Chemistry, Chemical Science, Engineering, or Biology.
• At least 2 years of experience in a Quality Control role as a chemist, or at least 6 months of experience in data verification in an FDA-regulated environment.
• Thorough knowledge of laboratory instruments, with demonstrated expertise in HPLC and GC, including validation, theory, preventive maintenance, and troubleshooting.
• Knowledge of global regulatory requirements, including FDA, cGMP, PICs, MHRA, and Health Canada.
• Must have led and successfully completed projects.
• Demonstrated proficiency in evaluation and certification programs, knowledge of USP terminology and requirements, and ability to apply standard principles, methods, and techniques to resolve technical problems.
• Good interpersonal and communication skills to support training, scheduling, and project management.
• Ability to work effectively with individuals at all organizational levels, across departments and functions, including Research and Development.
• High level of personal maturity and professional judgment.
• Self-directed, able to work independently, and able to prioritize data review.
• Strong time management, writing, organizational, critical-thinking, analytical, and problem-solving skills.
• Strong technical and/or leadership skills.
• High degree of initiative and flexibility, with ability to multitask in a fast-paced, changing environment.

Nice To Haves

• Working knowledge of training software, Lean concepts, laboratory investigations, and implementation of corresponding corrective and preventive actions.

Responsibilities

• Ensure cGMP compliance of electronic data.
• Independently review testing forms and batch records.
• Assist with instrument troubleshooting and maintenance as needed.
• Support Operational Excellence (Lean / Six Sigma) activities and contribute to sustainability and continued development in the work area.
• Apply Operational Excellence and industry best practices in the laboratory review environment to help prevent recurring events.
• Provide management with input on opportunities and issues as needed.
• Perform other related duties as assigned or required.

What This Job Offers

• Job Type: Full-time