Lead QC Associate III - Microbiology

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, dental, vision

401(k) plan

Paid vacation

Career growth opportunities

Job summary

FUJIFILM Biotechnologies in North Carolina seeks a Lead Associate 3, Quality Control (QC) Microbiology to oversee microbiology testing and train junior analysts, ensuring right-the-first-time batch disposition.

This role requires CGMP compliance, data integrity, and collaboration with management to escalate technical issues and drive continuous improvement in lab operations.

The position is based at the Morrisville/RTP site with a daytime shift and a team focused on bioscience breakthroughs.

Qualifications

• Bachelor’s degree in Life Science with 4+ years CGMP experience.
• Experience with data management systems (LIMS/TrackWise).
• Strong understanding of US Pharmacopeia and European Pharmacopeia.

Responsibilities

• Perform complex microbiological testing (Bioburden, Endotoxin, Culture Purity).
• Review data and author routine lab reports and EM trend reports.
• Support audits and regulatory inspections as SME.
• Ensure CGMP compliance and data integrity in the lab.
• Lead deviations investigations with management.
• Mentor junior analysts and provide technical guidance.
• Participate in equipment qualification and validation.

Skills

Aseptic techniques

Communication

Technical writing

Independent work

Project coordination

Data management systems

Lean six sigma

Collaboration

Audits/regulatory readiness

Education

Bachelor's degree in Life Science

Tools

LIMS

TrackWise

Job description

Position Overview

The Lead Associate 3, Quality Control (QC) Microbiology oversees and guides the critical operational functions of the QC Microbiology laboratory. This position holds the responsibility for conducting microbiological assays, as well as effectively trains junior analysts in these areas. The role is pivotal in guaranteeing “right the first time” execution to support timely batch disposition of manufacturing goods. Additionally, this role ensures technical issues are promptly escalated to laboratory management and upholds high standards of accuracy and efficiency within the laboratory operations.

Shift: Monday – Friday (8am – 5pm)

Company Overview

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. If you want to be a part of life-impacting projects alongside today’s most innovative biopharmaceutical companies, FUJIFILM Biotechnologies could be the right place for you.

From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether your expertise lies in research, manufacturing, or production, you’ll find a home here where your efforts directly improve patients’ lives. Together, let’s shape the future of healthcare.

Situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, our site is at the heart of a booming biotech hub surrounded by top universities, vibrant communities, and various outdoor opportunities.

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 complex microbiological testing (e.g., Bioburden, Endotoxin, Culture Purity, and Microbial Identifications) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
• Reviews technical data, authors routine and periodic laboratory reports (e.g., Environmental Monitoring (EM) trend reports) and contributes to technical documentation and assessments
• Supports client audits and regulatory inspections as an assay or method Subject Matter Expert (SME)
• Ensures laboratory maintains inspection readiness, data integrity, and Current Good Manufacturing Practice (CGMP) compliance
• Partners with management for technical services, such as initiating events (e.g., deviations and non-conformances) within quality systems
• Leads laboratory deviations and investigations
• Identifies problems, recommends and implements solutions while consulting with management
• Leads and participates in project developments from concept through execution, ensuring alignment with organizational goals
• Partners with laboratory management to schedule daily, weekly, and non-routine testing and tasks
• Provides technical guidance and mentorship to junior associates
• Participates in laboratory equipment qualification and validation activities
• Troubleshoots laboratory equipment, assay and method issues with the support of laboratory management

Knowledge, Skills, or Abilities:

• Advanced knowledge of aseptic techniques and behaviors
• Effective communication, both written and verbal
• Advanced technical writing and problem-solving skills
• Ability to complete work independently and with minimal supervision
• Ability to prioritize and organize work to deliver assignments according to established schedules and deadlines
• Ability to effectively collaborate with coworkers and internal clients
• In-depth understanding and knowledge of United States Pharmacopeia and European Pharmacopeia
• Ability to support audit readiness for the laboratory
• Ability to incorporate lean lab and six sigma principles into the work environment
• Ability to manage and complete tasks according to a structured plan
• Expertise with data management systems, such as TrackWise, LIMS, and capability to learn basic use and navigation within the systems
• Must be flexible to support 24/7 manufacturing facility

Minimum Requirements:

• Bachelor’s degree in Life Science, Pharmaceutical, or related field with 4+ years of experience in a CGMP environment
• Experience with data management systems (e.g., LIMS, TrackWise)

Preferred Requirements:

• 6+ years of experience in a CGMP Microbiology laboratory

Physical Requirements:

• Will work in environment which may necessitate respiratory protection
• Ability to discern audible cues
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color
• Ability to ascend or descend ladders, scaffolding, ramps, etc.
• Ability to stand for prolonged periods of time (240 minutes)
• Ability to sit for prolonged periods of time (240 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 33lbs
• Ability to bend, push or pull, reach to retrieve materials from 18" to 60" in height, and use twisting motions.
• Will work in warm/cold environments (0-100F range)

Benefits

• Our programs are designed to focus on maintainingand enhancing all pillars of health with arobust benefits package including medical, dental, vision and prescription drug coverage with the option of a Health Savings Account with company contributions.
• In addition, we offer an industry leading401(k) savings plan, insurance coverage, employee assistanceprograms and various wellness incentives.
• We support life-work balance withpaid vacation time, sick time, and company holidays.
• Explore a supportive environment that enriches both your personal and professional growth!

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]).