Position Overview

The Specialist, Quality Control (QC) Sample Management is responsible for handling samples manufactured at the site, sample and reference materials from outside sources (e.g., drug products), and stability samples. This role ensures sample transactions are documented by performing entries into electronic systems (LIMS and FreezerPro) or via forms outlined in the sample handling standard operating procedures (SOPs). Additionally, this role handles sample shipments according to stability protocols or shipping form instructions, supports continuous improvement projects, and provides input into the sample handling process.

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

 

• Receives, moves, and stores samples obtained from Manufacturing
• Performs stability sample tests and pulls in accordance with protocols and SOPs
• Receives, inspects, and inventories reference materials and samples from outside sources
• Documents sample receipt, storage, and movement via entries into Labware LIMS, FreezerPro, and on SOP forms
• Schedules deliveries and ships samples and reference materials according to stability protocols and shipping form instructions
• Supports chamber alarms and relocates samples as required for excursion
• Transfers samples according to instructions to maintain the required condition
• Identifies and partners with management to address sample issues that arise from manufacturing, laboratories, or the warehouse
• Supports continuous improvement projects and SOP revisions by providing input into the sample handling processes
• Maintains sample integrity in all aspects of working with sample and reference materials
• Provides support for site operations and responds to emergency work orders during off-hours, as needed
• Performs other duties, as assigned

 

Minimum Requirements:

 

• High School Diploma/GED with 4-6 years of sample management or shipping or related experience; or
• Associate degree in life science or related field with 2-4 years of sample management or shipping or related experience; or
• Bachelor’s degree in life science or related field with 0-2 years of sample management or shipping or related experience

 

Preferred Requirements:

 

• Experience with Trackwise and Labware LIMS
• Experience working in a Current Good Manufacturing Practice (CGMP) QC environment
• Previous sample management or sample shipping experience

 

 Working Conditions & Physical Requirements:

• May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearing conservation program.
• Ability to discern audible cues.
• Ability to inspect or perform a task with 20/20 corrected vision, visual acuity, including distinguishing color.
• Ability to stand for prolonged periods of time up to 120 minutes
• Ability to sit for prolonged periods of time up to 120 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 33 pounds.
• 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. (2-8 Degrees)

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 (HR_FDBU@fujifilm.com).