Analyst, QC Microbiology

FUJIFILM Electronic Materials (Europe) N.V.; Holly Springs (MS); On-site; USD 55,000 - 75,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, seeks an Analyst, QC Microbiology to perform microbial testing of in-process drug substances, drug products, EM/UM, and raw materials. You will assist with documentation, training, and project timelines within a GMP environment.

Responsibilities include environmental monitoring, sample logistics, and competitor data analysis to ensure test accuracy and regulatory compliance.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Experience in GMP QC Microbiology preferred.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Provides input to define protocols for sample collection and logistics, ensuring regulatory compliance.
• Coordinates testing materials and supplies.
• Plans and ensures materials are stocked and partners with procurement to optimize lab operations.
• Performs advanced microbiology testing for Bioburden, Endotoxin, and microbial findings.
• Performs sterility testing and validation processes and participates in isolator qualification procedures.
• Ensures accuracy and security of laboratory data and implements data management tools.
• Reviews laboratory testing results and provides analysis and interpretation, identifying trends.
• Troubleshoots assay issues and develops solutions to improve reliability.
• Leads lab support and maintenance, coordinating purchases of essential supplies.
• Supports CAPAs and deviations within quality systems.
• Participates in project development from concept to execution.

Skills

Microbiology testing

Quality systems

Data management

CAPA

Troubleshooting

Education

Bachelor's degree in scientific discipline

Tools

MALDI

MicroSeq

Laboratory instrumentation

Job description

Position Overview

The Analyst, QC Microbiology is responsible for the key operational aspects of the QC Microbiology laboratory. This role performs microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples under minimal supervision. The Analyst, QC Microbiology is responsible for all activities associated with testing in accordance with written procedures. This role participates in writing or assisting with document preparation and review, managing project timelines, conducting qualification and validation protocols, and assisting management with training and on-boarding of new staff, as needed and in addition to regular work duties and assignments.

Company Overview

FUJIFILM Biotechnologies is building the future of bioproduction in Holly Springs, North Carolina. By end of 2025, we’ll open North America’s largest end-to-end CDMO biopharmaceutical manufacturing facility, offering drug substance production, fill-finish, and packaging under one roof.

We’re looking for passionate, mission-driven people to help us realize this exciting vision and deliver the next vaccine, cure, or therapy. We offer a dynamic work environment and we’re proud to cultivate a culture that will fuel your purpose, energy, and drive—what we call Genki. Ready to shape the future of medicine? Let’s transform healthcare together!

Holly Springs, North Carolina, combines small-town warmth with proximity to Raleigh’s thriving tech scene, making it the perfect blend of community and opportunity.

Fujifilm is globally headquartered in Tokyo with over 70,000 employees across four key business segments of healthcare, electronics, business innovation, and imaging. We are guided and united by our Group Purpose of “giving our world more smiles.” Visit: https://www.fujifilm.com/us/en/about/region/careers

Job Description

What You'll Do:

• Supports environmental and utilities monitoring sample collection
• Provides input to define protocols for sample collection and logistics, ensuring compliance with regulatory standards
• Coordinates testing materials and supplies
• Plans and ensures materials are stocked. Partners with procurement, inventory management, and distribution to optimize laboratory operations
• Performs advanced microbiology testing by generating complex test data for in-process samples, raw materials, and environmental samples, providing analysis for Bioburden, Endotoxin, and microbial findings
• Performs Sterility testing and validation processes and participates in isolator qualification procedures and ensures effective routine operations and maintenance
• Ensures accuracy and security of laboratory information, implementing tools and protocols for data management
• Conducts comprehensive reviews of laboratory testing results and provides analysis and interpretation of results, identifying trends and making informed recommendations
• Under the direction of management, troubleshoots issues with laboratory assays and identifies underlying causes of assay failures and develops strategic solutions to improve test reliability
• Leads general laboratory support and maintenance initiatives by maintaining analytical instruments and laboratory resources, coordinating purchases and receipt of essential supplies
• Supports implementation and monitoring of CAPAs
• Partners with management to initiate and coordinate resolution for deviations and non-conformance events within quality systems
• Participates in project developments from concept through execution, ensuring alignment with organizational goals
• Performs additional duties, as needed

Minimum Requirements:

• Bachelor’s degree in scientific discipline with 0-1 years of experience

Preferred Requirements:

• BS within Microbiology, Chemistry, Biochemistry, Biology
• 2+ years of Intermediate experience in a GMP QC Microbiology
• Laboratory, knowledge of all compendial test methods (Bioburden, Endotoxin, sterility testing) preferred
• Ability to troubleshoot and maintain laboratory equipment and instrumentation
• Experience with microbial ID systems (MALDI, MicroSeq)

EEO Information

Fujifilm is committedto providing equal opportunities in hiring, promotion and advancement, compensation, benefits, and training regardless of nationality, age, gender, sexual orientation or gender identity, race, ethnicity, religion, political creed, ideology, national, or social origin, disability, veteran status, etc.

ADA Information

If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to our HR Department ([e-mail]).