Quality Systems Administrator for Herbalife's Quality Enterprise Systems, located at our state of art Innovation and Manufacturing facility in Winston-Salem, NC will be responsible for the following:
1) Maintenance, management and deployment of systems within Herbalife’s global Quality unit; this includes performing system administrative tasks and day-to-day support functions for Quality Systems, such as, but not limited to, Labware LIMS, Vaisala CMS, Valgenesis VLMS, QMS, etc.
2) Addressing and resolving system issues while optimally communicating any critical items to management, business process owners and users.
• Administer security changes to the quality systems applications (i.e Laboratory Information Management System (LIMS), Learning Management System (LMS), Quality Management Systems, etc.), including generation of new user accounts, changing security privileges as authorized, maintaining appropriate documentation.
• Maintain, manage and deploy quality systems applications (i.e. Laboratory Information Management System (LIMS), Quality Management System (QMS), etc.) to ensure compliance with regulatory requirements and company standards.
• Gather user requirements and develop functional specifications for system configuration changes. Configure the system, for identified changes, including designing, building and testing new configuration objects, and testing new system processes.
• Define and document scope of work for major upgrades through research and fact finding combined with an understanding of applicable systems and laboratory or business user requirements.
• Develops, modifies and maintains forms and interfaces for data entry into Quality Systems (includes LIMS & EM); creates specific report formats as needed.
• Provide end-user support on quality system applications by responding to user inquiries concerning systems operations and helping solve system and user issues; liaises with IT and vendor to investigate and resolve issues within agreed upon timeframe. • Act as main contact for the data management process between IT and end users.
• Deliver training to others as appropriate on specific areas of expertise.
• Assist in development of systems documentation and training materials/processes.
WHAT’S SPECIAL ABOUT THE TEAM:
The team develops cutting-edge quality infrastructure and applications, leveraging a diverse set of backgrounds to drive innovation and excellence. Our Quality Control team thrives on adaptability, teamwork, and a shared commitment to ensuring compliance, enhancing efficiency, and fostering a culture of continuous improvement.
SUPERVISORY RESPONSIBILITIES:
None
SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL:
Skills:
• Solid understanding of relational database management systems such as Oracle and MSSQL.
• Solid understanding ofQuality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH).
• Strong multi-functional and business knowledge to develop business systems and process alternatives.
• Solid understanding of enterprise systems such as Labware LIMS & Waters Empower, Oracle, Tracegains QMS, etc.
• Ability to work with internal functional groups and outside vendors.
• Ability to uphold and follow compliance standards.
• Display personal accountability for results and integrity.
• Exhibits positive people skills, and a team approach to problem resolution.
• Demonstrated capability to drive actions to closure.
• Exhibits drive for continuous improvement.
• Demonstrated initiative and capability to work independently.
• Demonstrated effective interpersonal, presentation, oral and written communication skills.
Experience:
• 3-5 years experience with administration of Quality Enterprise Systems in a pharmaceutical, nutraceutical or food environment.
Education:
• Bachelor’s Degree in Science, Engineering, IT, or a scientific related field
PREFERRED QUALIFICATIONS:
• Certifications such as Labware LIMS Administrator, Oracle Cloud, or equivalent.
• Experienced in building SAP Crystal Reports
• Knowledge of lean/six sigma methodology and tools.
PHYSICAL DEMANDS:
In general, the following physical demands are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be considered to perform the essential functions of the job.
WORK ENVIRONMENT:
In general, the following conditions of the work environment are representative of those that an employee encounters while performing the essential functions of this job. Reasonable accommodations may be considered to perform the essential functions of the job within the environment.
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