Senior QC Microbiologist

Fujifilm•Holly Springs, NC

16h•Onsite

About The Position

The Senior, QC Microbiology supports the QC, detecting, and mitigating microbial contamination across facilities, utilities, processes, and products. The role applies microbiology principles to validate sterilization, aseptic processing, and cleaning/sanitization; executes environmental and utility monitoring; and ensures compliance with FDA, EU, and global regulatory requirements. This position leads complex testing and data analysis, investigates contamination events and deviations, and partners cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS) to maintain product quality and patient safety. This role exists to ensure microbiological control, robust validation, and data-driven decision-making throughout the product lifecycle.

Requirements

Applies microbiology principles to validate sterilization, aseptic processing, and cleaning/sanitization
Executes environmental and utility monitoring
Ensures compliance with FDA, EU, and global regulatory requirements
Leads complex testing and data analysis
Investigates contamination events and deviations
Partners cross-functionally (Manufacturing, MSAT/Engineering, QA/QC, EHS)
Maintains LIMS/QMS records
Performs statistical analysis and trending
Implements and validates compendial and rapid microbiological methods (e.g., bioburden, endotoxin/LAL, sterility, microbial ID via MALDI-TOF/16S, qPCR, ATP bioluminescence)
Performs change controls and tech transfers
Develops and delivers training for operators and site staff on aseptic technique, gowning, EM practices, and contamination control behaviors
Performs qualification and requalification assessments
Partners with Manufacturing and MSAT/Engineering on facility design and improvements
Supports GEMBAs and change management
Supports internal audits and regulatory inspections
Remediates findings
Maintains inspection-ready documentation and areas
Performs and Exercises independent judgment to respond to EM excursions, water alerts, and in-process contamination signals
Escalates per SOP and CCS
Interprets regulations and standards to recommend controls and CAPAs
Selects appropriate test methods and sampling strategies within approved procedures
Decisions typically involve moderate to complex issues with significant quality impact
Consults with QA and site leadership for batch-impacting decisions

Responsibilities

Monitoring and trending of cleanrooms (air, surfaces, personnel), utilities (WFI/PW, clean steam, compressed gases), and materials for microbial contamination using compendial and rapid methods; ensure timely data review and alert/action response. This includes authoring trending reports and organisms’ evaluation.
Authors/executes protocols and reports for sterilization (SIP/terminal), aseptic process simulations (media fills), cleaning and sanitization validation, and disinfectant efficacy studies; align with Annex 1 and applicable standards.
Leads or supports investigations for deviations, OOS/OOT, EM excursions, and contamination events; perform root cause analysis (e.g., fishbone, 5-Whys, FMEA); define and implement effective CAPAs and effectiveness checks.
Performs statistical analysis and trending; maintain LIMS/QMS records; generate dashboards (EM performance, utilities, sterility assurance KPIs), and present to site governance for data-driven decisions.
Implements and validates compendial and rapid microbiological methods (e.g., bioburden, endotoxin/LAL, sterility, microbial ID via MALDI-TOF/16S, qPCR, ATP bioluminescence); perform change controls and tech transfers.
Develops and delivers training for operators and site staff on aseptic technique, gowning, EM practices, and contamination control behaviors; perform qualification and requalification assessments.
Partners with Manufacturing and MSAT/Engineering on facility design and improvements; support GEMBAs and change management.
Supports internal audits and regulatory inspections; remediate findings; maintain inspection-ready documentation and areas.
Performs and Exercises independent judgment to respond to EM excursions, water alerts, and in-process contamination signals; escalates per SOP and CCS.
Interprets regulations and standards to recommend controls and CAPAs; selects appropriate test methods and sampling strategies within approved procedures.
Decisions typically involve moderate to complex issues with significant quality impact; consults with QA and site leadership for batch-impacting decisions.
Perform other duties as assigned.