What are the responsibilities and job description for the LIMS Master Data Specialist position at cGxPServe?
Job Description
Job Description
Position Summary :
Responsible for the creation and execution of computer system validation document as well as providing operational support and guidance related to system use and improvement.
Responsibilities :
- Create and execute computer system validation documents (i.e., UAT, URS, OQ, PQ, etc.) as applicable and guide QC end users on the development of system enhancements with user requirements and business drivers.
- Provide electronic systems operational support and troubleshooting to end user.
- Create, deploy, review, and sustain electronic systems Master Data. Perform data verification, system integration (LIMS, ERP, and MES) for electronic systems.
- Own project, CAPA and deviation / investigation related tasks and / or continuous improvement efforts.
- Propose and implement improvements to electronic systems to optimize business process and improve efficiency. Collaborate with end users to develop business case.
- Anticipate mid- to long-term business needs and constraints. Support QC management in proposal and implementation of strategic initiatives.
- Anticipate and perform troubleshooting and problem solving independently.
- Train and mentor others on electronic systems use and operation.
- Translate business requirements into technical design requirements and communicate to partner organizations (e.g., IT) for system solution.
- Facilitate design, testing and subsequent deployment of solutions.
- Support health agency inspection as equipment area subject matter expert.
- Perform other tasks as required to support the electronic systems.
Requirements :
Specific Knowledge, Skills, Abilities :
