Lead QC Associate I (Chromatography)

Fujifilm
 Research Triangle Park, NC

Overview

The QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. 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. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter expert.

External US

The QC Lead Associate I will support a broad range of analytical disciplines within the Quality Control laboratory. This position will perform testing in the QC Analytical Chemistry laboratory. The individual performs high throughput, right-first-time laboratory work to meet production schedules and project milestones and will work with minimal supervision. They are expected to follow procedures and have familiarity and proficiency with a wide variety of analytical methods and supporting data management processes. The individual effectively and efficiently manages complex or difficult tasks. 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. The position primarily works with or may take direction from peers within the department, but may work more independently according to the scheduled workload. Individuals in this role are expected to have expertise within the assigned disciplines and act as subject matter experts.

This position will be in the chemistry laboratory across multiple chromatographic disciplines.

MAJOR ACTIVITIES AND RESPONSIBILITIES:

  • Laboratory sample analysis and data management- 90%
  • Other (training, projects, housekeeping, and related activities) — 10%
  • This position supports the manufacturing, revenue, and profit plans as they relate to the on-time and error free analysis of product and equipment related samples in the Quality Control Laboratory.

Other duties and responsibilities include:

  • 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)
  • 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, 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 services (such as preparing reports and initiating deviations) from preexisting templates.
  • Capable of meeting schedule RFT, high quality effort, taking initiative to communicate, coordinate, and adjust work efforts to achieve these objectives.
  • Trainer within areas of proficiency
  • 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

BACKGROUND REQUIREMENTS:

Minimum Education Requirements

  • BS/BA in science, preferably in chemistry, biochemistry, pharmaceutical sciences, or related technical field

Desired Experience

  • 6-8 years related laboratory experience (3 years required with relevant MS degree)

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 120 – 130 and Export Administration Regulations in 15 C.F.R. Part 730 – 774, 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 FDBUHR@fujifilm.com.

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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