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About the Role
The Data Verification Specialist ensures the Chemical Quality (CQ) laboratory complies with cGMP technical requirements, including data review, product testing, and project completion. This role provides independent data review of testing forms and batch records, and may assist in developing laboratory documents and evaluating new equipment and testing methodologies.
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.
- Incorporate best practices into the laboratory review environment.
- Provide input on opportunities and issues to management.
- Perform other related duties as assigned or required.
Requirements
- Must have led and successfully completed projects.
- Must be able to work effectively with all levels of individuals within the organization.
- Must be self-directed and demonstrate an ability to work independently in prioritizing data review.
- Must be able to multi-task and work in an ever-changing fast-paced environment.
- Must be at least 18 years of age.
- 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.
- Must be able to occasionally move and lift objects of up to 25 pounds.
Skills
- Thorough knowledge of various instruments with demonstrated expertise on technical instrumentation used in the lab, specifically HPLC and GC including validation, theory, preventative maintenance, and trouble shooting.
- Knowledge of global regulatory requirements (FDA, cGMP, PICs, MHRA, Health Canada).
- Demonstrate project abilities in proficiency evaluation and certification programs.
- Knowledge in USP terminology and requirements.
- Ability to apply standard principles, methods, and techniques in resolving technical problems.
- Good interpersonal and communication skills.
- High level of personal maturity and professional judgment.
- Strong time management skills.
- Effective writing skills.
- Highly organized.
- Critical thinker.
- Strong technical and/or leadership skills.
- Good analytical and problem-solving skills.
- High degree of initiative and flexibility.
- Working knowledge of training software, Lean concepts, Lab Investigations and respective corrective preventive action implementation preferred.
Location
- Office and laboratory environment
Work Type
- Full-time
Experience Level
- 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.
Education Level
- Bachelor’s Degree required: Chemistry, Chemical Science, Engineering, Biology
About the Company
- 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.
Equal Opportunity
- 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 austinhr@icumed.com.
- We are committed to providing equal access and opportunities for all candidates.