QC Lead Associate I

1 week ago

Research Triangle Park, United States FUJIFILM Diosynth Biotechnologies Full time
Overview


The QC Lead Associate I position is a position that supports a variety of microbiological disciplines within the Quality Control laboratory.

The individual performs laboratory work as assigned to meet production schedules and project milestones and will work with minimal supervision.

The incumbent is expected to follow procedures and gain familiarity with a wide variety of microbiological methods and supporting data management processes.

Microbiological disciplines common to the laboratory include but are not limited to aseptic technique, environmental and clean utility monitoring, bioburden and endotoxin determination, Gram staining, non-host (culture purity) testing, stock culture preparation and maintenance, cell culture maintenance, and associated viral titer assays.

The position primarily works with or may take direction from their manager and more senior department staff, but may work more independently according to the scheduled workload.

Individuals in this role are expected to have proficiency within the assigned disciplines.


Individuals in this role will have primary assigned responsibility for Environmental Monitoring functions or Microbiology support, depending upon department needs and individual capacity.

External US

Working location:
On-site

  • Laboratory sample analysis and data management - 90%
  • Other (training, projects, housekeeping, and related activities) - 10%

Required Skills/Education:

  • BS/BA in science, preferably in microbiology or biological sciences, or a related technical field
  • Develops advanced technique skills and is capable of working within established procedures to identify process improvements
  • Familiarity with basic statistical tools to analyze data in relation to trend results
  • Familiarity with data management processes such as Trackwise and LIMS or the capability to learn basic use and navigation within the systems
  • Can manage one or more tasks in a manner that promotes effective schedule adherence
  • Ability to identify and manage changing priorities in a productive and positive manner
  • Can communicate effectively with colleagues in the department, building trust and respect
  • Able to achieve Yellow Belt Certification within the company's Six Sigma program and apply learning principles to daily work
  • Technical writing skills (write basic protocols, prepare complex reports with or without a template)
  • Problem-solving and troubleshooting competencies

Desired Skills:

  • 4-6 years related laboratory experience (3 years required with relevant MS degree)
  • Has broad understanding and knowledge of procedures and practices in assigned area
  • Support all necessary laboratory and assay functions, including housekeeping, safety, logbook use and maintenance, equipment use and maintenance, method execution, and data review
  • 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 and summary reports
  • Notifies management and initiates events (such as deviations) in the quality systems
  • Prioritizes and organizes work to deliver assignments according to established schedules and deadlines
  • May coordinate logistics associated with laboratory testing or supporting documentation with others in the group
  • Trainer within areas of proficiency
  • May have some assigned project responsibilities, such as department representation, document development or review, troubleshooting, and protocol execution
  • Contributes to the achievement of team goals and a sense of teamwork within the unit and across the department
  • Identifies and solves problems while informing and consulting with area management

Physical Demands:

  • The position requires essential physical abilities, including but not limited to typing, standing, stooping, and the ability to move around in designated areas. The individual may need to exert physical effort such as lifting light objects up to 20 pounds, which accounts for approximately 10% of daily tasks. Additionally, there may be occasional requirements to push or pull loaded carts, also with light objects up to 20 pounds comprising 10% of daily tasks.

Visual Acuity:

  • The individual in this position should have the visual acuity required to perform activities such as preparing and analyzing data and figures; viewing a computer terminal engaging in extensive reading, using measurement devices, and/or assembly or fabrication at distances close to the eyes.

Environmental Conditions:

  • The individual in this position works in an indoor environment with controlled temperatures, avoiding extreme heat or cold. This role involves exposure to biohazardous materials.
FDBU works with technical data, technology and materials that are subject to U.S. export laws and regulations. This position will require access to technical data, technology and source code that is controlled under U.S. export laws and regulations, including but not limited to the International Traffic in Arms Regulations at 22 C.F.R. Parts and Export Administration Regulations in 15 C.F.R. Part , as may be amended. To conform to these laws and regulations, applicants must be U.S.

citizens, lawful permanent residents of the U.S., protected individuals as defined by 8 USC 1324(b)(a)(3) (i.e., asylees and refugees) or otherwise eligible for an export authorization from the U.S.

Department of State or U.S. Department of Commerce. Offers of employment will be contingent on the Company's ability to secure an export authorization.

FDBU is an Equal Opportunity Employer.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation, gender identify or any other protected class.

If an accommodation to the application process is needed, please e-mail

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 place.

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.

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