Biological Quality Analyst III | Microbiology & GMP

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

Job summary

Otsuka ICU Medical is seeking a BQ Analyst to perform routine and non-routine microbiological testing across manufacturing operations, ensuring compliance with cGMP, cGDP, and SOPs.

You will handle testing of non-viable and viable particulates, bioburden, endotoxin, and environmental monitoring, and maintain accurate electronic and hardcopy records in LIMS and related systems. Experience with PharmSpec or Labware is a plus.

Qualifications

• Must be at least 18 years of age.
• Bachelor's degree in microbiology or biological sciences (prefer 1 general microbiological course with lab experience).
• Minimum of 4–6 years of relevant experience preferred.

Responsibilities

• Perform microbiological and biological testing according to SLPs, STMs and SOPs.
• Generate and maintain accurate manual and electronic records.
• Draft or edit SOPs, STMs, and CAPA records under supervision.
• Support in resolving manufacturing problems and participating in investigations.

Skills

Microbiology knowledge

Laboratory instrumentation

Documentation & compliance

Microsoft Office proficiency

Data interpretation & trouble-shooting

Education

Bachelor's degree in microbiology or biological sciences

Tools

PharmSpec

MODA

LIMS (Labware)

Oracle

Microsoft Access

Excel

Job description

Otsuka ICU Medical is seeking a BQ Analyst to perform routine and non-routine microbiological testing across manufacturing operations, ensuring compliance with cGMP, cGDP, and SOPs.

You will handle testing of non-viable and viable particulates, bioburden, endotoxin, and environmental monitoring, and maintain accurate electronic and hardcopy records in LIMS and related systems. Experience with PharmSpec or Labware is a plus.