Stability Quality Analyst - GMP & Data Systems

Otsuka ICU Medical; Austin (TX); On-site; USD 60,000 - 86,000; Full time

Job summary

Otsuka ICU Medical in Austin, TX is seeking a Stability Analyst to coordinate planning, testing, and reporting of stability analysis, ensuring timely completion and high-quality data.

You will coordinate testing across departments and contract laboratories, oversee storage and transport of samples, and manage related LIMS data functions. A chemistry degree and GMP experience are required; travel is minimal and the role supports regulatory reporting and process improvement.

Qualifications

• Bachelor's in chemistry (preferred), or similar science or technical field.
• 1–2 years of recent pharmaceutical, medical device or regulated GMP experience.
• Experience with laboratory information management systems (LIMS).
• Proficiency with MS Office and basic statistical applications.

Responsibilities

• Coordinate stability planning and execution.
• Assist in stability lot selection and management.
• Coordinate testing activity to ensure timely completion of stability commitments.
• Support investigations into out of specification events related to stability.
• Coordinate required reporting of stability testing results.
• Oversee storage and transport of stability samples.
• Supervise stability data system management.
• Change control activity for documents related to stability activity.
• Provide training and leadership for analysts working with stability and LIMS data.
• Generate routine stability reports for management and regulatory purposes.

Skills

Quality Control

Stability testing

Data coordination

MS Office

Education

Bachelor's in Chemistry

Tools

MS Office

LIMS (LabWare)

Job description

Otsuka ICU Medical in Austin, TX is seeking a Stability Analyst to coordinate planning, testing, and reporting of stability analysis, ensuring timely completion and high-quality data.

You will coordinate testing across departments and contract laboratories, oversee storage and transport of samples, and manage related LIMS data functions. A chemistry degree and GMP experience are required; travel is minimal and the role supports regulatory reporting and process improvement.