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Associate 2, QC Microbiology (Wednesday to Saturday 2pm 12am)
Associate 2, QC Microbiology (Wednesday to Saturday 2pm 12am)Fujifilm • Durham County, North Carolina, USA
Associate 2, QC Microbiology (Wednesday to Saturday 2pm 12am)

Associate 2, QC Microbiology (Wednesday to Saturday 2pm 12am)

Fujifilm • Durham County, North Carolina, USA
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  • [job_card.full_time]
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Position Overview

The Associate 2 Quality Control (QC) Microbiology is responsible for performing routine microbiological testing of clean utility environmental monitoring and manufacturing batch samples. This role performs routine laboratory testing and support activities and actively participates in continuous improvement initiatives. 2nd shift.

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

Major Accountabilities

  • Provides facility support through the collection and testing of site clean utilities (e.g. water stem and compressed gases)
  • Performs microbiological testing (e.g. Bioburden Endotoxin and Growth Promotion) per department Standard Operating Procedures (SOPs) and test methods for samples associated manufactured batches
  • Reviews laboratory testing results and enters data into the Laboratory Information Management System (LIMS)
  • Performs environmental monitoring of controlled manufacturing environments
  • Ensures laboratory maintains inspection readiness data integrity and Current Good Manufacturing Practice (CGMP) compliance
  • Assists management with technical services such as initiating events (e.g. deviations and non-conformances) within quality systems
  • Identifies and solves problems while consulting and under the direction of management
  • Assists with laboratory equipment qualification and validation activities
  • Participates in project developments from concept through execution ensuring alignment with organizational goals. Performs other duties as assigned

Knowledge Skills or Abilities

  • Knowledge of aseptic techniques and behaviors
  • Effective communication both written and verbal
  • Technical writing and problem-solving skills
  • Ability to complete work both independently and under guidance from Supervision
  • Ability to systematically approach daily tasks
  • Ability to effectively collaborate with coworkers and internal clients
  • Knowledge of United States Pharmacopeia and European Pharmacopeia
  • Ability to support audit readiness for the laboratory
  • Willingness to incorporate lean lab and six sigma principles into the work environment
  • Ability to manage and complete tasks according to a structured plan
  • Knowledge and familiarity with data management systems (e.g. TrackWise LIMS) and capability to learn basic use and navigation within the systems
  • Must be flexible to support 24 / 7 manufacturing facility
  • Minimum Education and Experience Requirements

  • High School Diploma / GED with 6 years of Microbiology experience; or
  • Associates degree in Life Science Pharmaceutical or related field with 2-4 years of Microbiology experience; or
  • Bachelors degree in Life Science or Biology with 1-2 years of Microbiology experience
  • Experience with data management systems (e.g. LIMS TrackWise)
  • Preferred Education and Experience Requirements

  • 2 years of CGMP laboratory experience
  • Physical Demands

  • Ability to stand for prolonged periods of time 60 to 120 minutes
  • Ability to sit for prolonged periods of time 60 to 120 minutes
  • Ability to conduct activities using repetitive motions that include wrists hands and / or fingers.
  • Ability to operate machinery and / or power tools.
  • Ability to conduct work that includes moving objects up to 10 pounds.
  • Ability to bend push or pull reach to retrieve materials from 18 to 60 in height and use twisting motions.
  • Environmental Conditions

  • Will work in warm / cold environments. 2-8 C Range
  • 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.

  • #LI-Onsite
  • 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 :

    IC

    Key Skills

    Aeronautical,Healthcare Attorney,Fitness,General Services,Account Management,Export Documentation

    Employment Type : Unclear

    Department / Functional Area : Quality Control

    Experience : years

    Vacancy : 1

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    Wednesday Saturday • Durham County, North Carolina, USA

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