LIMS Administrator

US-GA-Union City
Job ID
2017-1072
Category
Quality Control

Overview

Dendreon is seeking a LIMS Administrator in our Georgia Quality Control Department.  This is an exciting position accountable for support of the Laboratory Information Management system (LIMS) in accordance with appropriate regulatory, corporate, scientific guidelines and Standard Operating Procedures (SOP).  The ability to function in a fast-paced, highly technical environment, and communicate effectively is essential to success.

Responsibilities

  • Responsible for managing the LIMS and its user accounts in Quality Control Laboratories supporting commercial operations at multiple operation sites.
  • Responsible for developing and implementing new functionality in LIMS and LIMS- instrument interfacing as required by evolving business needs.
  • Collaborate with IT and QA Validation Departments to facilitate validation activities; develop and/or execute test scripts as required.
  • Provide LIMS training, technical support, problem reporting and resolution(s) to QC, QA and Manufacturing staff.
  • Responsible for revision or development of LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation.
  • Ensure smooth operation of LIMS to support commercial operation in QC and Manufacturing.
  • Responsible for periodic data pulls for QC and QA.
  • Collaborate with IT to ensure adequate infrastructure support to LIMS.
  • Responsible for quality system and control system activities associated with LIMS such as change control, NC and its investigation, CAPA, change control, document revision etc.
  • May require supporting other QC functions.

Qualifications

  • B.S. degree in Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands-on laboratory experience preferred).
  • At least 5 years of experience with the use of LIMS and/or managing a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics).
  • Experience with laboratory instrumentation, software and interfacing is highly desired.
  • Laboratory skills in Flow cytometry, immunoassay and endotoxin test is a plus.
  • Thorough knowledge of cGMP/ICH/FDA regulations with 21 CFR Part11 and GAMP knowledge a plus
  • Experience with change control and software validation preferred  
  • Strong troubleshooting ability
  • Ability to prioritize and successfully manage complex and competing projects
  • Ability to become skilled at new applications and processes quickly--broad experience with software on PC and server platforms and programming experience a plus.
  • Strong customer service orientation and the ability to work independently and with QC laboratory staff to maintain or enhance the system.
  • Excellent oral and written communication skills

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