Posted in Information Technology 30+ days ago.
POSITION SUMMARY STATEMENT:
The Quality Systems Administrator II will serve as a Systems Administrator for Herbalife Nutrition's quality management systems (QMS). This position is responsible for maintaining, managing and deploying the QMS within Herbalife Nutrition. This includes performing system administrative tasks and day-to-day support functions for QMS (i.e., Laboratory Information Management Systems (LIMS), Business Intelligence (BI) tools, Validation Lifecycle Management System, etc.) and addressing, recommending and resolving system issues and appropriately communicating gating items to management, business process owners and users. Additionally, this role will be expected to identify, evaluate, implement and support automation solutions and systems to meet or exceed Herbalife Nutrition's Quality initiatives.
Administer security changes to the QMS, including LIMS, BI tools, Validation Lifecycle Management System, as well as creating 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 testing new system processes. Lead implementation and roll-out.
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 any Quality system; creates specific report formats as needed based on regulatory and user requirements.
Provide end-user support on quality system applications by responding to user inquiries concerning systems operations and helping troubleshoot system and user issues; liaises with IS and vendor to investigate, validate and resolve issues within agreed upon timeframe. Act as primary contact for the data management & application processes between IS and system users.
Provide training to others as appropriate on specific area of expertise.
Collaborate with IS and Validation departments to facilitate Computer System Validation (CSV) activities. Develop and/or execute validation test scripts and write validation reports as required.
Identify and document reporting requirements and develop tool to auto-generate required reports.
Standardizes and optimize processes based on findings and analysis.
Track, manage and lead all QMS-related projects using project management tools. Lead steering committee meetings as needed.
Develop standard operating procedures, user guides and training manual, business continuity and disaster recovery plan for quality systems, and other relevant documentation.
Implement industry's best practices in Herbalife Nutrition environment.
Demonstrated knowledge and experience 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).
Strong cross-functional and business knowledge to develop business system and process alternatives.
Strong knowledge of an enterprise/cornerstone system (i.e., LIMS & Waters Empower, Oracle, Agile)
Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations.
Experience in implementing and maintaining GXP computer systems in a validated state with the ability to assess compliance risks.
Ability to work with internal functional groups and outside vendors.
Ability to represent compliance standards.
Excellent verbal communication skills.
Display personal accountability for results and integrity.
Exhibits positive people skills, and a team approach to problem resolution.
Exhibits drive for continuous improvement.
Demonstrated capability to drive actions to closure.
Demonstrated initiative and capability to work independently.
Demonstrated capability to turn abstract concepts into tangible work product with moderate supervision.
Demonstrated effective interpersonal, presentation, oral and written communication skills.
7+ years of industry related experience
Systems administrator experience in application to pharmaceutical, nutraceutical or food environment
Bachelor’s degree in Science or Technology
Master’s degree in Science, Technology or Business Administration