Lead QC Microbiology Analyst & SME Trainer

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, QC Microbiology to lead key lab operations.

You will perform advanced microbial testing on in-process drug substances, drug products, and raw materials, and train others as SME for at least one test. The role requires independent work with minimal supervision, collaboration with management on decisions, and a focus on LEAN and Six Sigma to improve processes and ensure GMP compliance.

Qualifications

• Bachelor’s with 2+ years of relevant Microbiology experience OR
• Master’s with 0 years of experience
• Experience with aseptic production & support
• 1-3 years in a GMP environment
• Advanced understanding of GMP, GLP, GDP requirements
• Advanced knowledge in Microbiology theory
• Advanced knowledge of Microbiology testing and laboratory experience
• LEAN lab and Six Sigma training/certification
• Intermediate familiarity with statistical tools to analyze data
• Intermediate LIMS software training
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP)

Responsibilities

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a SME and trainer for at least one test
• Leads sample collection and manages sample logistics for testing
• Supports testing for all qualification and study directed testing
• Supports investigation of routine OOS assays and events
• Conducts qualification and validation protocols
• Leads sterility testing
• Reviews intermediate lab testing results
• Troubleshoots complex assays
• Writes and assists with document preparation and review
• Manages project timelines
• Assists management with training and onboarding of new staff
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes
• Champions projects and project management as assigned
• Performs other duties, as assigned

Skills

Microbiology knowledge

GMP knowledge

LEAN/Six Sigma training

LIMS experience

Statistical analysis

Document control

Education

Bachelor’s degree in Microbiology or related field

Master’s degree in Microbiology or related field

Tools

LIMS

TrackWise

Job description

FUJIFILM Biotechnologies in Holly Springs, NC is seeking a Sr. Analyst 1, QC Microbiology to lead key lab operations.

You will perform advanced microbial testing on in-process drug substances, drug products, and raw materials, and train others as SME for at least one test. The role requires independent work with minimal supervision, collaboration with management on decisions, and a focus on LEAN and Six Sigma to improve processes and ensure GMP compliance.