Contract Lead QC Associate, Data Reviewer in Research Triangle Park, NorthCarolina | Careers at NC RTP FDBU Office


Requisition ID 2021-15661
Category Quality Control
Company (Portal Searching) FUJIFILM Diosynth Biotechnologies U.S.A., Inc.
Overview

The Contract QC Lead Associate, Data Reviewer position is a position that supports a broad range of analytical disciplines within the Quality Control laboratory. The individual performs data review for testing of 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 requiring data review 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.

This is a contract position that is anticipated to last 12 months.


External US

The Contract QC Lead Associate, Data Reviewer position is a position that supports a broad range of analytical disciplines within the Quality Control laboratory. The individual performs data review for testing of 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 requiring data review 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.

This is a contract position that is anticipated to last 12 months.

Other duties and responsibilities include:

  • Responsible for data review 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 the data review for CAPA's, audit actions, deviations, lab investigations, method revisions, and other related Quality System activities
  • 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
  • Conveys holistic view of data in context of validity, reliability, and impact relative to the batch at hand and other related batches and processes.
  • Proactively identifies and implements improvements with minimal oversight
  • Manages multiple assignments of increasing complexity and responsibility
  • Generate reports and recommendations based on statistical data, can identify statistically significant and impactful events
  • Performs or leads laboratory investigations, identifies deviations and implements corrective actions
  • Applies process improvement methodologies that contribute to solutions of technical issues
  • Can communicate in a manner that fosters cooperation and creates a safe environment for those involved

MAJOR ACTIVITIES AND RESPONSIBILITIES:

Describe briefly the major activities of the position. Indicate the approximate percentage of time spent on each activity.

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

ORGANIZATIONAL STRUCTURE:

This position reports directly to a supervisor or manager in the Quality Control Department; there are no direct reports or subordinate working relationships to this position.

SCOPE MEASURES:

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.

BACKGROUND REQUIREMENTS:

List the minimum academic requirements, professional certifications, years of experience and specific skills required for this position. Describe any unique working condition; for example, chemical handling, lifting, etc.

Minimum Education Requirements

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

Desired Experience

  • 8+ years related laboratory experience (4 years required with relevant MS degree)

Specific Skills and Competencies

  • Possesses an understanding and knowledge of procedures and practices in assigned area
  • Has developed basic technique skills and is capable of working within established procedures
  • Capable of working with a moderate degree of supervision and organizing own time
  • Familiarity with basic statistical tools to analyze data in relation to trends results
  • Familiarity with data management processes such as Trackwise or LIMS or capability to learn basic use and navigation within the systems.
  • Capable of identifying and escalating problems to superiors
  • Can manage one or more tasks in a manner that promotes effective schedule adherence.
  • Ability to manage changing priorities in a productive and positive manner
  • Can communicate effectively with colleagues in department, building trust and respect
  • Ability to learn and incorporate lean lab and six sigma principles into daily work environment.
  • Able to achieve Yellow Belt Certification within company six sigma program
  • Technical writing skills (write basic protocols, prepare complex reports without a template)
  • Problem solving and troubleshooting competencies
  • Able to make informed and timely decisions independently
  • Ability to contribute beyond own product/department

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 (see application details).

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.

Posted
10/02/2021
Salary Range
$58,000.00 - 92,000.00
per Year
Salary range estimated by
Location
Durham, NC 27709, US
Apply Now