WuXi AppTec

  • Quality Systems Administrator

    Job Locations US-PA-Philadelphia
    Job ID
    2018-3890
  • Overview

    The Master Control System Administrator (SA) is responsible for effective provisioning, installation/configuration, operation, and maintenance of Master Control Quality Management software. This individual works closely with the software provider to resolve system issues, propose enhancements, deploy updates, and test and implement additional functionality within the system. The System Administrator will assist project teams and process owners with technical issues in the initiation and planning phases of module implementation, including the definition of needs, benefits, and technical strategy, as well as support of staff in executing, testing and rolling out solutions. Provides guidance for quality related issues and consults with QA Management to resolve complex quality issues in a timely manner

    Responsibilities

    • Develop and maintain installation and configuration management procedures.
    • Contribute to and maintain system standards.
    • Following up on support issues proactively to provide timely updates and resolutions to end users.
    • Work with the vendor to troubleshoot and resolve application issues. Coordinate and communicate with impacted stakeholders as needed.
    • Work with teams to apply application version upgrades in a timely manner and configure/add new services as needed.
    • User administration, including creating, changing, and disabling user accounts per approved procedures.
    • Able to perform all major day to day administrative hands-on tasks.
    • Work with existing process owners to deploy new modules, providing advanced training to support process owners becoming module power users.
    • Work to develop reports, based on needs of end users and management, to enable efficient real time reporting.
    • Support governmental, organizational, client, and vendor audits as needed.
    • Stay current with changes to GXP, including FDA and EU and other regulatory bodies as well as guidance documents (ie: ICH, ISPE, etc.).
    • Write and revise SOPs as necessary to ensure compliance, efficiency and clarity.
    • Participate in quality and process improvement initiatives, and project teams.
    • Coordinates area training along with new employee training.
    • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
    • Works under minimal supervision from supervisor or senior personnel.
    • Ability to work in a team environment and independently as required
    • Maybe required to work Holidays and weekends.
    • Performs other duties as assigned.

     

    Qualifications

    Experience / Education:      

    • Bachelor's Degree
    • 3 years of experience as an analyst/administrator for an electronic data management system.
    • Prior industry experience preferred.
    • Experience with FDA 21 CFR Part 11 validated systems preferred.

     

    Knowledge / Skills / Abilities:

    • Excellent problem solving and troubleshooting skills.
    • Strong time management skills.
    • Understanding of 21 CFR Part 11 and EU Annex 11 requirements for validated electronic systems.
    • Demonstrated ability to interact effectively with customers of all organizational levels.
    • Understanding of industry requirements and trends toward preserving data integrity, including FDA Guidance for Industry on "Data Integrity and Compliance with cGMP.”
    • Familiarity with and previous experience working with Master Control, preferably in a System Administration capacity.
    • Familiarity with HTML language preferred.
    • Provide troubleshooting expertise to end users on an ad hoc basis, consulting with Master Control as needed.
    • Knowledge of FDA GLP/ cGMP requirements.
    • Knowledge of EU cGMPs highly desirable.
    • Ability to use judgment as dictated by the complexity of the situation.
    • Ability to understand and follow verbal or demonstrated instructions.
    • Ability to work effectively as part of a team and to exhibit effective interpersonal skills.
    • Ability to receive, comprehend and to effectively communicate detailed information through verbal and written communication.
    • Travel is required 5% , Domestic/International, Daily / Overnight

    Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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