Analyst 1, QC Microbiology

Fujifilm • Holly Springs, NC

14h • Onsite

About The Position

The Analyst 1, QC Microbiology is responsible for key operational activities in the QC Microbiology laboratory. Under minimal supervision, the role performs microbial testing of in-process drug substance, drug product, environmental and utility monitoring (EM/UM), and raw-material samples in accordance with written procedures. The position also contributes to document preparation and review, project timeline management, qualification and validation protocols, and training and onboarding of new staff as needed, in addition to regular duties.

The role supports environmental and utilities monitoring, performs microbiology testing and analysis, maintains laboratory operations and information, and contributes to quality-system activities such as CAPAs, deviations, and non-conformance resolution. The position requires flexibility to support a 24/7 manufacturing facility.

Requirements

• Bachelor’s degree in a scientific discipline.
• 0–1 years of experience.
• Basic understanding of GMP, GLP, and GDP requirements.
• Excellent attention to detail, communication, basic technical writing, and problem-solving skills.
• Ability to manage and complete tasks according to a structured plan, independently and with occasional supervisory guidance.
• Ability to support laboratory audit readiness.
• Knowledge of basic sciences and microbiology laboratory methods and procedures.
• Ability to work cross-functionally with a diverse team and collaborate with junior team members.
• Ability to quickly learn procedures and practices in the assigned area.
• Familiarity with fundamental statistical tools for analyzing data and trends.
• Basic understanding of data-management systems such as Trackwise or LIMS, or ability to learn their basic use and navigation.
• Ability to learn and incorporate lean laboratory and Six Sigma principles into daily work.
• Flexibility to support a 24/7 manufacturing facility.
• Ability to discern audible cues; perform visual tasks with 20/20 corrected vision, including distinguishing colors; ascend or descend ladders, scaffolding, or ramps; stand and sit for periods of up to 60 minutes; perform repetitive wrist, hand, or finger motions; move objects weighing up to 10 pounds; and bend, push, pull, reach for materials 18 to 60 inches high, and twist.
• Work in an environment operating a motor vehicle or Powered Industrial Truck.

Nice To Haves

• Bachelor’s degree in Microbiology, Chemistry, Biochemistry, or Biology.
• Two or more years of intermediate experience in a GMP QC Microbiology laboratory.
• Knowledge of compendial Bioburden, Endotoxin, and sterility testing methods.
• Ability to troubleshoot and maintain laboratory equipment and instrumentation.
• Experience with microbial identification systems such as MALDI or MicroSeq.

Responsibilities

• Perform microbial testing of in-process drug substance, drug product, environmental and utility monitoring, and raw-material samples according to written procedures.
• Support environmental and utilities monitoring sample collection and provide input on collection protocols and logistics.
• Coordinate testing materials and supplies; plan stock levels and partner with procurement, inventory management, and distribution.
• Perform advanced microbiology testing and analyze Bioburden, Endotoxin, and microbial findings.
• Perform sterility testing and validation processes; participate in isolator qualification and support effective routine operations and maintenance.
• Ensure the accuracy and security of laboratory information and implement data-management tools and protocols.
• Review laboratory test results, interpret findings, identify trends, and make recommendations.
• Troubleshoot laboratory assay issues under management direction, identify causes of assay failures, and develop solutions to improve test reliability.
• Maintain analytical instruments and laboratory resources, coordinate purchases, and receive essential supplies.
• Support implementation and monitoring of CAPAs.
• Partner with management to initiate and coordinate resolution of deviations and non-conformance events within quality systems.
• Participate in projects from concept through execution, ensuring alignment with organizational goals.
• Assist with document preparation and review, project timeline management, qualification and validation protocols, and training and onboarding of new staff as needed.
• Perform additional duties as needed.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level