• LIMS Administrator, Quality Control

    Job Locations US-GA-Union City
    Job ID
    2018-1361
    Category
    Quality Control
  • Overview

    Dendreon is seeking a laboratory LIMS Administrator in our Union City 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

    • Managing the LIMS and its user accounts in Quality Control Laboratories supporting commercial operations at multiple operation sites
    • Developing and implementing new functionality in LIMS and LIMS- instrument interfacing as required by evolving business needs.
    • Collaborating with IT and QA Validation Departments to facilitate validation activities; developing and/or executing test scripts as required
    • Providing LIMS training, technical support, problem reporting and resolution(s) to QC, QA and Manufacturing staff
    • Revising or development of LIMS functional requirement specifications and user requirement specifications as well as other relevant documentation
    • Ensuring smooth operation of LIMS to support commercial operation in QC and Manufacturing
    • Periodic data pulls for QC and QA
    • Collaborating with IT to ensure adequate infrastructure support to LIMS
    • Quality system and control system activities associated with LIMS such as change control, NC and its investigation, CAPA, change control, document revision etc
    • Additional QC activities / responsibilities as needed and required to support other QC functions

    Qualifications

    • B.S. degree in Computer Sciences, Information Technology, Biology, Microbiology, Biochemistry or other relevant scientific discipline (with hands-on laboratory experience preferred)
    • At least 5 years of experience with the use of Labware LIMS and/or managing a LIMS in a cGMP Quality Control department or in a FDA regulated industry (drugs/biologics)
    • Experience in Labware LIMS v7.0 upgrade and required qualifications is desirable
    • Experience with laboratory instrumentation, software and their 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

    Options

    Sorry the Share function is not working properly at this moment. Please refresh the page and try again later.
    Share on your newsfeed