Data Verification Specialist

Otsuka ICU Medical • Austin, TX

3d

About The Position

The Data Verification Specialist ensures that the Chemical Quality (CQ) laboratory complies with cGMP technical requirements. The role supports training, data review, pre- and post-sterile product testing, investigational testing and investigations, and completion of area-related projects. It independently reviews testing forms and batch records generated within applicable laboratories. The Specialist may also assist with laboratory document review and development, evaluation and installation of new laboratory equipment, and new testing methodologies.

The role requires technical expertise with laboratory instrumentation, particularly HPLC and GC, and knowledge of global regulatory requirements. The Specialist supports Operational Excellence activities and works independently to prioritize data review while collaborating across organizational functions. The position is performed in an office and laboratory environment and typically requires travel less than 5% of the time.

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 and demonstrated technical expertise with laboratory instruments, specifically HPLC and GC, including validation, theory, preventative maintenance, and troubleshooting.
• Knowledge of global regulatory requirements, including FDA, cGMP, PICs, MHRA, and Health Canada.
• Must have led and successfully completed projects.
• Knowledge of USP terminology and requirements and demonstrated ability to apply standard principles, methods, and techniques to resolve technical problems.
• Good interpersonal and communication skills to perform training, scheduling, and project management responsibilities.
• Ability to work effectively with individuals at all organizational levels and across departments, functions, and Research and Development; demonstrated maturity and professional judgment.
• Ability to work independently and prioritize data review.
• Strong time management, writing, organizational, critical-thinking, analytical, and problem-solving skills.
• Strong technical and/or leadership skills.
• Initiative, flexibility, ability to multitask, and ability to work in a fast-paced, changing environment.
• Must be able to occasionally move and lift objects weighing up to 25 pounds.

Nice To Haves

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

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 sustain and further develop the work area.
• Apply Operational Excellence and industry best practices in the laboratory review environment to prevent recurring events.
• Provide management with input on opportunities and issues as necessary.
• Perform other related duties as assigned or required.
• May assist in reviewing and developing laboratory documents, including SOPs.
• May assist with evaluation and installation of new laboratory equipment and development of new testing methodologies.
• Support training, scheduling, and project management activities.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level