Microbiology Lab Quality Analyst

Otsuka ICU Medical LLC; Austin (TX); On-site; USD 65,000 - 90,000; Full time

Job summary

Otsuka ICU Medical LLC seeks a BQ Analyst to perform routine and non-routine microbiological testing in support of manufacturing, ensuring compliance with cGMP and SOPs. The role emphasizes instrument maintenance, data entry, and accurate documentation of results.

The position requires a Bachelor’s degree in microbiology or biological sciences, strong attention to detail, and ability to work under supervision within a fast-paced lab environment in Austin, TX.

Qualifications

• Bachelor’s degree in microbiology or biological sciences with hands-on lab exposure.
• Experience in QC/QA laboratory environments and cGDP/cGMP awareness.
• Familiarity with LIMS, data entry, and documentation control.

Responsibilities

• Perform routine and non-routine microbiological testing per SOPs and STMs.
• Maintain and operate lab instruments and ensure calibration and maintenance.
• Prepare batch records and electronic laboratory records with accurate data.
• Draft protocol changes and support CAPA investigations under supervision.
• Support investigations and data analysis to resolve quality issues.

Skills

Microbiology knowledge

Laboratory safety

Attention to detail

Documentation practices

Communication skills

Excel/Office

Education

Bachelor's degree in Microbiology or Biological Sciences

Tools

LIMS (Labware/PharmSpec)

Spectrophotometer

Microscope

Pipettes

Job description

Otsuka ICU Medical LLC seeks a BQ Analyst to perform routine and non-routine microbiological testing in support of manufacturing, ensuring compliance with cGMP and SOPs. The role emphasizes instrument maintenance, data entry, and accurate documentation of results.

The position requires a Bachelor’s degree in microbiology or biological sciences, strong attention to detail, and ability to work under supervision within a fast-paced lab environment in Austin, TX.