Lead QC Associate II - Raw Materials

FUJIFILM Biotechnologies; Milwaukee (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Health insurance

401(k) plan

Paid vacation

Job summary

FUJIFILM Biotechnologies is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. You will oversee sampling, testing, and releasing incoming raw materials to ensure GMP and USP/EP/JP compliance and data integrity.

You will act as SME for method transfers, validations and deviations, drive continuous improvement, and support documentation and CAPA activities within the Quality Control laboratory.

Qualifications

• BS/BA in science with at least 2 years of direct experience.

Responsibilities

• Sampling, testing, and release of incoming raw materials.
• Lead investigations, CAPAs, deviations, and quality system activities.
• Provide technical writing and data interpretation for reports.
• Lead method transfers, validations and qualifications.
• Support data integrity and continuous improvement in QC.

Skills

GMP compliance

Problem solving

Data review

Technical writing

Method transfer

Education

BS/BA in science

Tools

FTIR

RAMAN

Karl Fischer

Polarimeter

Refractometer

Job description

The Quality Control group at FDBU group is seeking a Lead QC Associate II – Raw Materials at our Bioprocess Innovation Center in Morrisville, NC. The QC Lead Associate II is responsible for sampling, testing, and releasing incoming raw materials in compliance with GMP, regulatory standards (USP/EP/JP), and internal quality procedures. This role ensures materials meet specifications prior to use in manufacturing and supports data integrity, documentation, and continuous improvement within the Quality Control laboratory.

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:

• Responsible for a broad range of laboratory support functions and procedures as assigned, demonstrating expertise in technical skills, disciplines, and procedures within assigned discipline area(s).
• Demonstrated subject matter expert and responsible for CAPA’s, audit actions, deviations, lab investigations, method revisions, and other relayed Quality System activities.
• Takes lead in problem solving and troubleshooting, makes recommendations for mitigation and improvement.
• Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution and data review.
• Lead/SME for method transfers, method validations and method qualification.
• Embrace lean lab and six sigma principles and applies them to laboratory processes
• Reviews technical data and provides expert review and input to new methods and revisions. Creates data reviews, summary reports, and provides expert interpretation of data.
• Prioritizes and organizes work to deliver assignment according to established schedules and deadlines. May coordinate logistics associated with laboratory testing or supporting documentation with others in-group.
• May provide technical writing services (such as preparing reports and initiating deviations) from pre-existing templates.
• Assists with deviations, lab investigations, procedure changes, method transfer planning.
• May have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution.
• Identifies and solves problems while informing and consulting with area management.
• Conveys holistic view of data in context of validity, reliability, and impact relative to the batch at hand and other related batches and processes.
• Proactively identifies and implements improvements with minimal oversight.
• Generate reports and recommendations based on statistical data, can identify statistically significant and impacting events.
• Performs or leads laboratory investigations, identifies deviations and implements corrective actions.
• Apply process improvement methodologies that contribute to solutions of technical issues.

Minimum Requirements

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field with at least 2 years of direct experience.

Preferred Requirements

• Experience with compendial analysis, USP, EP and JP, method validation/verification, FTIR, RAMAN, Karl Fischer, Polarimeter, and Refractometer.
• 8+ years related laboratory experience

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 maintaining and enhancing all pillars of health with a robust 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 leading 401(k) savings plan, insurance coverage, employee assistance programs and various wellness incentives. We support life-work balance with paid vacation time, sick time, and company holidays. Explore a supportive environment that enriches both your personal and professional growth!

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]).