Senior Microbiology Quality Analyst

Otsuka ICU Medical LLC; Austin, Northern (TX, KY); Hybrid; USD 65,000 - 90,000; Full time

Job summary

Otsuka ICU Medical LLC in Austin, TX is seeking a BQ Analyst to perform routine and non-routine testing supporting manufacturing operations. You will handle microbiological testing, instrument maintenance, data recording, and compliance with cGMP, cGDP, SOPs, and SLAs.

The ideal candidate has a Bachelor's in microbiology or biological sciences and 4-6 years of relevant experience, with hands-on experience in LIMS and QC laboratory practices.

Qualifications

• Bachelor’s degree in microbiology or biological sciences with relevance to QC labs.
• 4–6 years of relevant experience in microbiology or bioprocess QC.
• Experience with LIMS, data capture and GMP documentation.

Responsibilities

• Perform microbiological and biological testing per SOPs and STMs.
• Operate and maintain laboratory instruments in support of testing.
• Generate and maintain manual and electronic lab records per cGDP.
• Draft document changes and support CAPA and investigations.
• Schedule and train lab personnel; ensure timely product release.

Skills

Microbiology

Laboratory instrumentation

LIMS

Microsoft Excel

Education

Bachelor's degree in microbiology or biological sciences

Tools

HIAC/CLIMET

SAS

FTIR

Laminar airflow hood

BSC (biosafety cabinet)

Job description

Otsuka ICU Medical LLC in Austin, TX is seeking a BQ Analyst to perform routine and non-routine testing supporting manufacturing operations. You will handle microbiological testing, instrument maintenance, data recording, and compliance with cGMP, cGDP, SOPs, and SLAs.

The ideal candidate has a Bachelor's in microbiology or biological sciences and 4-6 years of relevant experience, with hands-on experience in LIMS and QC laboratory practices.