Stability Quality Lead (GMP & Data Systems)

Otsuka ICU Medical LLC; Austin (TX); In loco; USD 65.000 - 95.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

Analytical thinking

Leadership

Formazione

Bachelor's in chemistry or related field

Strumenti

LabWare LIMS

MS Office

Statistical software

Descrizione del lavoro

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.