QO Lab Analyst II (Microbiology) (1st Shift)

POSITION SUMMARY

The QO Laboratory Analyst supports routine testing and review of microbiology data in a GMP environment, analyzing finished product samples prior to commercial release.

POSITION RESPONSIBILITIES

• Analyze raw materials, qualified utilities, APIs, and/or finished product samples to support the company quality program in the microbiology laboratory.
• Perform environmental monitoring.
• Support microbiological programs including release/stability testing, sanitization/sterilization validation, media prep, and growth promotion.
• Perform, document, record checks, and troubleshoot qualitative or quantitative assays using standard and automated instrumentation.
• Interpret/evaluate data for accuracy, precision, trends, and potential GMP impact; recommend corrective actions.
• Participate in laboratory investigations as required.
• May write routine protocols or conduct assay/process/instrument qualifications.
• May train others and recommend/execute process improvements.

TECHNICAL SKILLS REQUIREMENTS

• Proficiency in aseptic technique.
• Ability to quickly learn new skills/techniques.
• High productivity, multitasking ability, low error rate, and attention to detail.
• Flexibility/agility in a changing environment.
• Good lab technique to avoid cross-contamination or sample misidentification.
• Able to perform routine and non-routine analyses from compendial and internal sources.

EDUCATION AND EXPERIENCE

• AAS or BA/BS in Microbiology, Biology, or related science preferred.
• Previous QA/QC experience in GMP pharmaceutical manufacturing desired.
• Preferred: GMP documentation, drug product formulation, in-plant laboratory, Incoming Inspection, SAP, LIMS.
• Occasional lifting (<35 lbs). Must not be cephalosporin sensitive.

SHIFT HOURS

May require weekends and/or holidays.