Lead QC Associate 2

FUJIFILM Holdings America Corporation; Northern (KY); Hybrid; USD 65,000 - 90,000; Full time

Benefits offered by this job

Medical benefits

401(k) plan

Paid time off

Health Savings Account

Job summary

FUJIFILM Biotechnologies is seeking a Lead QC Associate II to support a broad range of analytical disciplines within the Quality Control laboratory. The role performs high throughput, right-first-time work to meet production schedules and project milestones with minimal supervision.

You will serve as SME for CAPAs, deviations, investigations, method revisions, and data reviews, leading problem solving and continuous improvement through lean lab and Six Sigma principles.

Qualifications

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field with at least 2 years of direct experience.
• Strong experience with HPLC.

Responsibilities

• Lead laboratory support functions and procedures within the assigned discipline.
• Serve as SME for CAPAs, deviations, investigations, method revisions, and data reviews.
• Lead problem solving and recommendations for mitigation and improvement.
• Coordinate lab testing, data review, and documentation.
• Lead/SME for method transfers, validations, and qualifications.
• Apply lean lab and Six Sigma principles to processes.

Skills

HPLC

Education

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences

Tools

Trackwise

Deviation writing

Job description

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, 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.
• 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)

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.

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]).