Data Verification Specialist

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 85,000; Full time

Job summary

Otsuka ICU Medical LLC seeks a Data Verification Specialist to assure the CQ laboratory remains compliant with cGMP, perform independent data review of testing forms and batch records, and assist with SOPs and new methods. The role supports Lean/Six Sigma initiatives and requires strong analytical and communication skills.

The candidate will work within a collaborative QA environment, handling instrument maintenance and data integrity across electronic systems in a fast-paced lab setting.

Qualifications

• Bachelor’s degree required in a related field.
• Minimum 2+ years in QC as chemist or 6+ months data verification in FDA-regulated environment.

Responsibilities

• Ensure cGMP compliance of electronic data.
• Perform independent data review of testing forms and batch records.
• May assist in instrument troubleshooting and maintenance.
• Support Operational Excellence (Lean / Six Sigma) activities.
• Provide input on opportunities and issues to management.
• Perform other related duties as assigned or required.

Skills

Data review

cGMP awareness

Regulatory knowledge

Communication skills

Interdepartmental collaboration

Project management

Problem solving

Education

Bachelor's Degree in Chemistry / Chemical Science / Engineering / Biology

2+ years in Quality Control or 6+ months in data verification (FDA regulated)

Tools

HPLC

Gas Chromatography (GC)

Job description

Position Summary

The primary responsibility of the Data Verification Specialist is to ensure the Chemical Quality (CQ) laboratory is in compliance with cGMP technical requirements, training, data review, pre and post sterile product testing, investigational testing and investigations, and completion of area related projects. The position is responsible for providing the independent data review of testing forms and batch records generated within the applicable laboratories. The Specialist may assist in the review and development of laboratory documents including standard operating procedures (SOPs), evaluation and installation of new lab equipment, and new testing methodologies.

• Ensure cGMP compliance of electronic data.


• Perform the independent data review of testing forms and batch records.


• May assist in instrument troubleshooting and maintenance.


• Actively support Operational Excellence (Lean / Six Sigma) activities and be accountable for sustainability and continued development in the work area.


• Incorporate best practices from Operational Excellence, industry practices into the laboratory review environment to prevent reoccurring events.


• Provide input on opportunities and issues to management as necessary.


• Perform other related duties as assigned or required.

Job Description

Position Summary

The primary responsibility of the Data Verification Specialist is to ensure the Chemical Quality (CQ) laboratory is in compliance with cGMP technical requirements, training, data review, pre and post sterile product testing, investigational testing and investigations, and completion of area related projects. The position is responsible for providing the independent data review of testing forms and batch records generated within the applicable laboratories. The Specialist may assist in the review and development of laboratory documents including standard operating procedures (SOPs), evaluation and installation of new lab equipment, and new testing methodologies.

Essential Duties & Responsibilities

• Ensure cGMP compliance of electronic data.


• Perform the independent data review of testing forms and batch records.


• May assist in instrument troubleshooting and maintenance.


• Actively support Operational Excellence (Lean / Six Sigma) activities and be accountable for sustainability and continued development in the work area.


• Incorporate best practices from Operational Excellence, industry practices into the laboratory review environment to prevent reoccurring events.


• Provide input on opportunities and issues to management as necessary.


• Perform other related duties as assigned or required.

Knowledge & Skills

• Thorough knowledge of the various instruments with demonstrated expertise on the technical instrumentation used in the lab, specifically HPLC and GC including validation, theory, preventative maintenance, and trouble shooting. Individual must have knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada).


• Must have led and successfully completed projects.


• Demonstrate project abilities in proficiency evaluation and certification programs including knowledge in USP terminology and requirements and has exhibited the ability to apply standard principles, methods, and techniques in resolving technical problems.


• Must have good interpersonal and communication skills to successfully perform all aspects of training, scheduling and project management.


• The incumbent must be able to work effectively with all levels of individuals within the organization (interdepartmental, cross functional, Research and Development) and have exhibited a high level of personal maturity and professional judgment.


• Must be self-directed and demonstrate an ability to work independently in prioritizing data review.


• Possess strong time management and effective writing skills, highly organized and be a critical thinker.


• Must have strong technical and/or leadership skills with good analytical and problem-solving skills.


• Demonstrate a high degree of initiative and flexibility.


• Must be able to multi-task and work in an ever-changing fast-paced environment.


• Working knowledge of training software, Lean concepts, Lab Investigations and respective corrective preventive action implementation preferred.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age


• Bachelor’s Degree is required: Chemistry, Chemical Science, Engineering, Biology


• Must have 2+ years of experience in a Quality Control role as a chemist or a minimum of 6 months experience in data verification in an FDA regulated environment.

Work Environment

• Office and laboratory environment.


• Must be able to occasionally move and lift objects of up to 25 pounds


• Typically requires travel less than 5% of the time

About Us

Innovation, Impact, and Purpose.

Find Your Future Here.

We manufacture the critical IV solutions providers count on to deliver consistent, reliable care. Each product we make helps ensure patients receive the therapies they need without disruption.

When you work here, you become part of something bigger—a team dedicated to reliability and innovation. No matter the role, your work directly strengthens the healthcare supply chain and impacts patients nationwide.

We offer opportunities for growth, collaboration, and meaningful contributions, all in pursuit of a mission that truly matters.

Join us and help shape the future of IV solutions.

EEO Statement

Otsuka ICU Medical is committed to being an Equal Opportunity Employer. We ensure that all qualified applicants receive fair consideration for employment regardless of race, color, nationality or national origin, ethnicity, sex, gender, religion or belief, marital or civil partnership status, sexual orientation, pregnancy or maternity, age, disability, or protected veteran status.

If you are an individual with a disability and need reasonable accommodation to participate in the employment selection process, please contact us at [e-mail]. We are committed to providing equal access and opportunities for all candidates.

Otsuka ICU Medical EEO Policy Statement

Know Your Rights: Workplace Discrimination is Illegal Poster

Otsuka ICU Medical CCPA Notice to Job Applicants