Quality Systems Administrator (Hybrid)

Overview:

THE ROLE:

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 Laboratory Information Management System (LIMS), Vaisala Continuous Monitoring System (CMS), Valgenesis Validation Lifecycle Management System (VLMS), Quality Management System (QMS), etc.
2. Addressing and resolving system issues and appropriately communicates gating items to management, business process owners and users.

HOW YOU WOULD CONTRIBUTE:

• Administer security changes to Herbalife Nutrition’s Quality Enterprise Systems, including creation of new user accounts, changing security privileges, as authorized, and maintaining appropriate documentation.
• 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 system processes.
• Formulates and defines 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 systems; 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 information systems (IS) and vendors to investigate and resolve issues within agreed upon timeframe. Act as main contact for data management process between IS and system users.
• Assist with developing and updating process workflows, system documentation, training manuals and/or job aids based on the system functions and the workflow processes.
• Support Computer System Validation (CSV) activities, as needed.
• Deliver training to others as appropriate on specific area of expertise.

WHAT’S SPECIAL ABOUT THE TEAM:

Our success is driven by accountability, collaboration, respect, and clarity.

SUPERVISORY RESPONSIBILITIES:

None

Job Qualifications:

SKILLS AND BACKGROUND REQUIRED TO BE SUCCESSFUL

Skills:

• Demonstrated knowledge with the administration of Quality Enterprise Systems
• Working knowledge of relational database management systems such as Oracle and MSSQL
• Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH)
• Understanding of programming logic and ability to create, view, and debug application programs.
• Strong cross-functional and business knowledge to develop business system and process alternatives
• Strong written and verbal communication skills, with an ability to translate complex technical concepts.
• Strong interpersonal skills with a focus on collaboration, knowledge sharing, and expertise as it relates to the job functions.

Experience:

• 3-5 years of experience in systems administration in pharmaceutical, nutraceutical, and/or food industries.
• Experience in software/systems lifecycle development methodology.
• Experience authoring and reviewing user documentations, standard operating procedures, on-the-job-training, and other controlled documents.

Education:

• Bachelor’s degree in Science or Technology

PREFERRED QUALIFICATIONS:

• Knowledge of FDA, EU, and global GMP's including Good Automated Manufacturing Practices, 21 CFR Part 11, and EU cGMP Annex 11.
• Strong knowledge in Data Integrity Requirements for FDA, EU, and global regulatory authorities.

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.

• Must be able to see, hear, speak and write clearly in order to communicate with employees and/or other customers
• Light office work, some light lifting, and walking may be required
• 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.

• The office is clean, orderly, properly lighted and ventilated
• Noise levels are considered low to moderate

Other Voluntary Benefit Programs include a 401(k) plan, Wellness Incentive Program, Employee Stock Purchase Plan (ESPP), Supplemental Life/Critical Illness/Hospitalization/Accident Insurance, and Pet Insurance. Paid time off includes Company-observed U.S. Holidays, Floating Holidays, Vacation, Sick Time, a Volunteer Program, Paid Maternity and Paternity Leave, Bereavement Leave, Personal Leave and time off for voting.