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

Scorpion Therapeutics; Kalamazoo (MI); On-site; USD 60,000 - 90,000; Full time

Job summary

Scorpion Therapeutics is seeking a QO Laboratory Analyst to support routine microbiology testing in a GMP environment, reviewing data and ensuring compliance prior to release.

The role involves analyzing raw materials, utilities, APIs and finished products, performing environmental monitoring, assisting with validation, documentation, and investigations as needed.

Qualifications

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

Responsibilities

• Analyze raw materials, utilities, APIs, and 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.

Skills

Aseptic technique

Learning ability

Attention to detail

Flexibility

Lab technique

Analytical testing

Education

BS in Microbiology/Biology

QA/QC experience in GMP pharma

Tools

SAP

LIMS

GMP documentation

Job description

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.