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Lead QC Associate 2

Job Location:

Durham County, NC - USA

Monthly Salary: Not provided by the employer

Posted: 30 August 2026 (5 days ago)

Application Deadline: 27 November 2026

Vacancies: 1 Vacancy

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Department:

Quality Control

Job Summary

Position Overview

The Quality Control group at FDBU group is seeking a Lead QC Associate II to support a broad range of analytical disciplines within the Quality Control laboratory. The individual performs high throughput right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. Analytical disciplines common to the laboratory include but are not limited to: Chromatography HPLC Concentration determination pH Total Organic Carbon Gel based protein separation IEF Plate Based Assay and conductivity.

Company Overview

At FUJIFILM Biotechnologies were leading the charge in advancing tomorrows medicines. If you want to be a part of life-impacting projects alongside todays 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 youll find a home here where your efforts directly improve patients lives. Together lets 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 70000 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: Description

What Youll 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 CAPAs 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.
Notifies management and initiates events (such as deviations) in the quality systems.
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.
Capable of meeting schedules with RFT high quality effort taking initiative to communicate coordinate and adjust work efforts to achieve these objectives.
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.
Contributes to achievement of team goals and sense of teamwork within unit and across department
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.
Performs or leads laboratory investigations identifies deviations and implements corrective actions.

Qualifications:

Bachelor of Science or Bachelor of Arts - preferably in Chemistry Biochemistry Pharmaceutical Sciences or related technical field with at least 2 years of direct experience.
Strong experience with HPLC

Preferred Qualifications:

Experience with compendial analysis USP EP and JP method validation/verification FTIR RAMAN Karl Fischer Polarimeter and Refractometer
Previous expeirence with Trackwise and deviation writing

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)

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 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!

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 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.

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 ().

Required Experience:

IC

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About Company

Fujifilm

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