Analyst 1, QC Microbiology

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC, is seeking an Analyst 1, QC Microbiology to perform microbial testing of in-process drug substance, product, EM/UM, and raw materials under supervision. The role requires adherence to written procedures, data management, and contributor to document preparation and training.

Ideal candidates hold a life science degree with 0–1 year experience, understanding GMP/GDP, and possess meticulous attention to detail, problem-solving, and collaboration

Qualifications

• Bachelor's degree in a life science with 0–1 year experience.
• Understanding of GMP, GLP, GDP requirements.
• Basic technical writing and problem solving.

Responsibilities

• Supports environmental and utilities monitoring sample collection.
• Plans and ensures materials are stocked; coordinates with procurement.
• Performs advanced microbiology testing and analyzes Bioburden, Endotoxin.
• Conducts reviews of laboratory results and identifies trends.
• Maintains instruments and supports CAPAs.
• Assists with training and onboarding.

Skills

GMP knowledge

Microbiology testing

Data analysis

Documentation

Cross-functional

Education

Bachelor's degree in science

Tools

LIMS

TrackWise

MALDI

MicroSeq

Job description

Position Overview

The Analyst 1, 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 1, 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've 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.

Knowledge, Skills, and Abilities

• Excellent attention to detail. Looks for opportunities for continuous improvement.
• Basic technical writing and problem-solving skills.
• Excellent verbal and written communication skills.
• Able to manage and complete tasks according to a structured plan.
• Able to complete tasks both independently and with occasional guidance from Supervision.
• Ability to support audit readiness for the laboratory.
• Self-driven, dedicated, and systematic and can plan your day in a structured way.
• Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself.
• Understanding of GMP, GLP, GDP requirements.
• Knowledgeable in basic sciences and Microbiology laboratory methods and procedures.
• Ability to work cross-functionally with a diverse team.
• Self-motivated and collaborate with junior team members.
• Ability to quickly learn and understand the knowledge of procedures and practices in assigned area.
• Familiarity with fundamental statistical tools to analyze data in relation to trends results.
• Basic understanding and familiarity with data management systems such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
• Ability to learn and incorporate lean lab and six sigma six principles into daily work environment.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor's degree in scientific discipline with 0-1 years of experience.
• Basic understanding of GMP, GLP, GDP requirements.

Preferred Qualifications

• Bachelor's 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).

Physical Requirements:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions. While performing the duties of this job, the employee is required on a regular basis to:

• Will work in environment operating a motor vehicle or Powered Industrial Truck.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual activity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramp, etc.
• Ability to stand for prolonged periods of time for up to 60 minutes.
• Ability to sit for prolonged periods of time for up to 60 minutes.
• Ability to conduct activities using repetitive motions that include wrists, hands, and/or fingers.
• Ability to conduct work that includes moving objects up to 10 pounds.
• Ability to bend, push or pull, reach to retrieve materials from 18'' to 60'' in height, and use twisting motions.

*LI-Onsite

EEO Information

Fujifilm is committed to 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]).