Specialist, QC Sample Management

Durham County, NC - USA

Monthly Salary: Not Disclosed

Posted on: 4 hours ago

Vacancies: 1 Vacancy

Job Summary

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 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

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
Bachelors 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)

*#LI-Onsite

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:

Position OverviewThe 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 entri...