Lead QC Associate II - Raw Materials

About Us

At FUJIFILM Biotechnologies, we’re leading the charge in advancing tomorrow’s medicines. From our Bioprocess Innovation Center to our cGMP-compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Our site is situated at the cross-section of Morrisville and Research Triangle Park (RTP), North Carolina, 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 healthcare, electronics, business innovation, and imaging segments.

About the Role

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.

Responsibilities

• Perform a broad range of laboratory support functions and procedures, demonstrating expertise in technical skills and disciplines.
• Serve as a subject matter expert for CAPAs, audit actions, deviations, lab investigations, method revisions, and other Quality System activities.
• Lead problem-solving and troubleshooting, making recommendations for mitigation and improvement.
• Support laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution, and data review.
• Lead or serve as subject matter expert for method transfers, validations, and qualifications.
• Apply lean lab and six sigma principles to laboratory processes.
• Review technical data and provide expert input for new methods and revisions.
• Create data reviews, summary reports, and provide expert interpretation of data.
• Prioritize and organize work to meet established schedules and deadlines.
• Coordinate logistics associated with laboratory testing or supporting documentation.
• Provide technical writing services, such as preparing reports and initiating deviations from pre-existing templates.
• Assist with deviations, lab investigations, procedure changes, and method transfer planning.
• Manage assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution.
• Identify and solve problems while consulting with area management.
• Convey a holistic view of data in context of validity, reliability, and impact on batches and processes.
• Proactively identify and implement improvements with minimal oversight.
• Generate reports and recommendations based on statistical data, identifying significant and impacting events.
• Perform or lead laboratory investigations, identify deviations, and implement corrective actions.
• Apply process improvement methodologies to resolve technical issues.

Requirements

• BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field with at least 2 years of direct experience.
• Experience with compendial analysis, USP, EP, and JP.
• Experience with method validation/verification, FTIR, RAMAN, Karl Fischer, Polarimeter, and Refractometer (preferred).
• 8+ years of related laboratory experience (preferred).

Physical Requirements

• Work in environments that may require respiratory protection.
• Ability to discern audible cues.
• Ability to inspect or perform tasks with 20/20 corrected vision, including color distinction.
• Ability to ascend or descend ladders, scaffolding, or ramps.
• Ability to stand or sit for prolonged periods (240 minutes).
• Ability to conduct activities using repetitive motions of wrists, hands, and/or fingers.
• Ability to move objects up to 33 lbs.
• Ability to bend, push, pull, reach (18" to 60" in height), and use twisting motions.
• Work in warm/cold environments (0-100°F range).

Schedule

Monday – Friday (8:00 AM – 5:00 PM).

Benefits

• Medical, dental, vision, and prescription drug coverage with the option of a Health Savings Account and company contributions.
• Industry-leading 401(k) savings plan.
• Insurance coverage and employee assistance programs.
• Paid vacation time, sick time, and company holidays.
• Wellness incentives and a supportive environment for personal and professional growth.