Senior Analyst 1 - QC Microbiology

Position Overview

The Senior Analyst 1, QC Microbiology is responsible for leading key operational aspects of the QC Microbiology laboratory. The Senior Analyst 1, QC Microbiology performs and trains other team members on the microbial testing of all in-process drug substance, drug product, EM/UM, and raw materials samples. This role is responsible for all activities associated with testing in accordance with written procedures. This role primarily works independently with minimal supervision as needed, consults with management on key decisions.

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

• Executes advanced lab testing and support for all laboratory assays for all samples, and acts as a Subject Matter Expert (SME) and qualified trainer of at least one test.
• Leads sample collection and manages sample logistics for testing.
• Supports testing for all qualification and study directed testing.
• Supports investigation of routine OOS assays and events.
• Conducts qualification and validation protocols.
• Leads sterility testing.
• Reviews intermediate lab testing results.
• Troubleshoots complex assays.
• Writes and assists with document preparation and review.
• Manages project timelines.
• Assists management with training and on-boarding of new staff as needed.
• Embraces LEAN lab and six sigma principles and applies them to laboratory processes.
• Champions projects and project management as assigned.
• Performs other duties, as assigned.

Knowledge, Skills, and Abilities

• Excellent attention to detail. Seeks opportunities for improvement and suggests ideas for improvement projects.
• Advanced technical writing and problem-solving skills.
• Excellent verbal and written communication skills. Ability to review and interpret data Ability to present information to the team.
• Able to develop and assign tasks according to a structured plan. Ability to overcome and respond to challenges.
• Able to complete tasks independently and with occasional guidance from Supervision as needed. Ability to implement structured plans.
• Drives performance, identifies areas of improvement.
• Ability to support audits and client interactions.
• Self-driven, dedicated, and systematic and can plan your day and develop plans for others in a structured way.
• Flexible, has a positive attitude, positive energy and open for changes and interested in developing yourself and others.
• Ability to work cross-functionally with a diverse team and represent the team.
• Self-motivated and collaborates with analysts.
• Champions a collaborative attitude for the team.
• Must be flexible to support 24/7 manufacturing facility.

Minimum Qualifications

• Bachelor’s with 2+ years of relevant Microbiology experience; OR,
• Master’s with 0 years of experience.
• Experience with aseptic production & support.
• 1-3 years in a GMP environment.
• Advanced understanding of GMP, GLP, GDP requirements.
• Advanced knowledge in Microbiology theory.
• Advanced knowledge of Microbiology testing and laboratory experience.
• LIMS experience.
• Experience with document control including reviewing and editing technical documents.
• LEAN lab and six sigma six training and/or certification
• Intermediate familiarity with fundamental statistical tools to analyze data in relation to trends results
• Intermediate LIMS software training.
• Knowledge or training of FDA regulations (cGMP, cGLP, cGDP).

Preferred Qualifications

• Master’s with 1+ years of experience.
• 4+ years of previous experience working within QC Microbiology or with GXP or quality systems is an advantage.
• Advanced experience in a GMP QC Microbiology Laboratory, advanced knowledge of all compendial test methods (Bioburden, Endotoxin, Sterility testing).
• Advanced experience with microbial ID systems, ability to trouble-shoot complex equipment and instrumentation (MALDI, MicroSeq).
• Advanced LIMS / Trackwise software training.
• Experience working within a QC laboratory environment commissioning Pharmaceutical and/or laboratory facilities

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:

• 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 discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• 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.
• Will work in small and/or enclosed spaces.
• Will work in heights greater than 4 feet.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via-email, the internet or in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.

*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 ([email protected]).