Immunomedics, Inc.

  • Quality Control Manager, LIMS

    Job Locations US-NJ-Morris Plains
    Posted Date 1 month ago(12/10/2018 9:11 AM)
    Job ID
    2018-1380
    # of Openings
    1
    Category
    Scientific Engineering
  • Overview

    This individual will provide leadership during deployment of laboratory information management systems (LIMS), manage the design, installation validation of the system and have responsibility for maintenance of the system throughout its lifecycle. This includes LIMS master data transfer/load, SOP generation/updating, and system validation activities such as test script execution and user support.

    Responsibilities

    • In conjunction with the Head of Quality Control, provide leadership and shape the strategic implementation of the LIMS program for improvement of cGMP laboratory documentation and tracking processes and quality system level enhancement.
    • Provide support for computer systems managed by Quality Control, LIMS system administration, validation, SOP management, user support, training and change management. Responsibilities include SOP management, LIMS genealogy and deviations.
    • Ensure that proposed additions and changes comply with data & governance standards, rules and policies. Lead and guide the Data Maintenance activities. Participate in Data Life Cycle Design and Management activities.
    • Create, maintain, and update all LIMS modules and master data; including, but not limited to, programs, sample types, lists, instruments, equipment, and classifications. Provide leadership support for LIMS projects; including, but not limited to, business and user requirements, consultant support, and template building.
    • Participate in analytical investigations by performing action steps (testing), querying LIMS records, and obtaining other relevant information and documentation to support the investigation process.
    • Responsible for the ongoing operation of LIMS applications. Responsible for the site-specific data operations, change management, and maintenance of documentation.
    • Responsible for maintaining proactive communication with respect to ongoing & completed change. Analyzes problems and escalates issues when needed to appropriate levels of Business.
    • Lead complex multi-site projects to establish global standards by representing the local site to establish global standards. Participate in group, cross-departmental and global business performance improvement projects.
    • Defines roles and accountabilities for the LIMS team, hires, integrates and develops high quality talent capable of delivering against the department’s goals and objectives.
    • Establishes and communicates performance objectives for staff that are consistent with the businesses unit goals, and site Quality objectives. Defines and enforces performance measures, provides developmental feedback and coaching and creates a collaborative environment that attracts, develops and retains the best talent. Ensures that personnel are provided adequate training, education and experience to perform their GMP related job function effectively.
    • Participates in compliance related teams working towards the goal of continuous improvement.
    • Participates in the site team which prepares for, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
    • Verifies compliance with applicable Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications.

    Qualifications

    • BS/BA in Life Sciences, Computer Science or equivalent.
    • Minimum 5 years’ experience in FDA or equivalent regulated industry, biotechnology or pharmaceutical, performing Quality functions such as SOP and protocol writing, quality specification development, batch release functions, deviation investigation and resolution, auditing, etc.
    • Strong knowledge of cGMP and cGLP regulations, safety and environmental requirements. Experience with laboratory information management systems (LIMS) and other related digital quality tools required.
    • Minimum 3 years’ experience working with SAP, Trackwise, LIMS, eDMS; preferred working knowledge of SharePoint.
    • Minimum of five (5) years relevant experience in analysis and Quality Control of biological molecules.
    • Minimum of three (3) years of leadership/supervisory experience.

    Options

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