Lead QC Associate

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.

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:

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.
• 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…