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About the Role
Coordinate planning, testing, and reporting of stability analysis, ensuring timely and quality completion of all stability testing and accurate data reporting. This includes managing inter-departmental coordination, external contract testing, storage relationships, sample transport, and related data systems.
Responsibilities
- Assist in stability lot selection and management.
- Coordinate stability planning and execution.
- Coordinate testing activity to ensure timely completion of stability commitments.
- Support investigations into unexpected events related to stability (out of specification, out of trend, etc).
- Coordinate required reporting of stability testing results.
- Oversee storage transport of stability samples.
- Supervise stability data system management.
- Manage change control activity for documents and processes related to stability.
- Provide training and leadership for analysts performing stability and LIMS data functions.
- Generate reports related to stability for routine management and regulatory purposes.
- Perform other related duties as assigned or required.
Requirements
- Must be at least 18 years of age.
- At least 1-2 years of recent pharmaceutical, medical device or regulated GMP experience is required.
- Thorough knowledge of various software programs such as MS Office, statistical applications, etc.
- Experience in investigation and management of out of specification and/or deviation events related to laboratory testing.
- Experience with GMP change management and document change processes.
- Experience with laboratory information management systems (LIMS, e.g., LabWare).
Skills
- Familiarity with Quality Control Laboratory testing in a pharmaceutical environment.
- Familiarity with compendial stability storage and testing requirements.
Location
- Office environment with floor support as required
- Laboratory environment
Work Type
- Full-time
Experience Level
- 1-2 years
Education Level
- Bachelor’s in chemistry (preferred), or similar science or technical field.
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.