Analyst 1, All QC - Day Shift

FUJIFILM Biotechnologies; Holly Springs (NC); On-site; USD 52,000 - 65,000; Full time

Job summary

FUJIFILM Biotechnologies in Holly Springs, NC is seeking an Analyst, Quality Control (QC) to join a 24/7 team supporting urgent testing for manufacturing batches. The role involves performing routine tests across QC labs and assisting with environmental monitoring and sample logistics.

You will work under supervision, learn SOPs, review results, help maintain data integrity, and contribute to CAPAs and deviations within quality systems.

Qualifications

• Bachelor’s degree in science with 0–1 year of experience.
• Basic GMP/GLP/GDP knowledge.
• Willingness to work a 24/7 manufacturing facility schedule.

Responsibilities

• Performs basic testing across QC labs per SOPs for manufacturing batches.
• Coordinates sample collection and logistics for testing.
• Maintains data integrity and supports CAPAs and deviations.
• Supports 24/7 manufacturing facility operations and equipment upkeep.
• Reviews results, identifies trends and suggests improvements.

Skills

Attention to detail

Communication skills

Data analysis basics

Cross-functional teamwork

Education

BSc in Science

Microbiology/Chemistry/Biochemistry/Biology

Tools

Trackwise/LIMS

Job description

This position supports a 2/2/3 schedule from 6am-6pm. The Analyst, Quality Control (QC) All QC Team is responsible for performing routine testing requited for Urgent/STAT testing of manufacturing batch samples, clean utility, environmental monitoring. This role is part of a 24x7 team that supports testing/sampling across all of the QC laboratories required for urgent testing/Manufacturing support. The role will learn and perform testing/sampling across multiple labs in QC.

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

• Performs basic testing that spans all of the QC labs (e.g., Bioburden, Endotoxin, HPLC, UV280, TOC, etc.) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches.
• 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.
• 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 Laboratory, knowledge of all compendial test methods preferred.
• Ability to troubleshoot and maintain laboratory equipment and instrumentation

Physical Requirements

• Will work in environment operating a motor vehicle or a Powered Industrial Truck.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 2020/corrected vision, visual acuity, including distinguishing color.
• Ability to ascend or descend ladders, scaffolding, ramps, 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.

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]).