Quality Associate, Stability

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 95,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX is seeking a Stability Analyst to coordinate planning, testing, and reporting of stability analyses for pharmaceutical products. You will ensure timely completion, manage data systems, and collaborate across departments and with contract testing providers.

Responsibilities include stability lot selection, testing coordination, investigation of out-of-spec events, and preparation of regulatory reports.

Qualifications

• Bachelor's in chemistry or related field (preferred).
• 1–2 years GMP/pharma or regulated environment experience required.
• Familiarity with LIMS (LabWare) and MS Office; basic statistical tools.

Responsibilities

• Coordinate stability planning and testing activities across departments.
• Oversee storage and transport of stability samples and data management.
• Generate reports for stability and regulatory purposes; support investigations of out-of-spec events.

Skills

Analytical thinking

Leadership

Education

Bachelor's in chemistry or related field

Tools

LabWare LIMS

MS Office

Statistical software

Job description

Position Summary

Coordinate planning, testing, and reporting of stability analysis. Ensures all stability testing is completed in the required time frame in a quality manner and that all resulting data is reported as required. Includes coordination of testing between multiple departments as well as outside contract testing and storage relationships to achieve tasks. Includes coordination of storage and transport of samples. Includes management of related data systems.

Essential Duties & 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.
• Change control activity for documents and processes related to stability activity.
• Training and leadership for analysts performing stability and LIMS data functions.
• Generation of reports related to stability, for routine management and regulatory purposes.
• Perform other related duties as assigned or required.

Knowledge & Skills

Familiarity with Quality Control Laboratory testing in a pharmaceutical environment. Majority is chemical testing, though some biological testing is also involved. Familiarity with compendial stability storage and testing requirements.

Minimum Qualifications, Education & Experience

• Must be at least 18 years of age.
• Bachelor's in chemistry (preferred), or similar science or technical field.
• At least 1-2 years of recent pharmaceutical, medical device or regulated GMP experience is required with a 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).

Work Environment

Office environment with floor support as required for project execution as well as laboratory environment. Ability to lift up to 50 pounds, as related to shipping, storage, or transport of stability sample cases. 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

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