LIMS Master Data Analyst 904 views

Responsibilities:

• Excellent employment opportunity for a Technician 2 – Quality Systems in the Raritan, NJ area.
• An Analyst 2, LIMS Master Data Analyst, Lab Systems works within the eLIMS CoE, and independently creates, updates and maintains high-quality Master Data within eLIMS, and translates specifications within the eLIMS system by utilizing current business processes.
• The Analyst takes ownership by completing any incoming requests in a timely manner.
• They will escalate any issues and understand the impact on other customers when changing/updating existing Master Data.
• In order to maintain high-quality data, they collaborate with customers to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.
• Able to mentor, lead, and train team members.
• The Analyst collaborates with more than 1 customer from the different platforms (e.g. LM, SM, PDMS) to fully understand the Master Data requirements and will review all configurations for accuracy and completeness.
• Able to lead small projects within the CoE, e.g. Harmonization/standardization of processes.
• Integrates instruments and applications within eLIMS, performs user acceptance testing
• 75 -85 % – Creates, updates, reviews & approves Master Data (release and stability) including worksheet templates, worklist templates, and sample plans
• 10 – 20% – Maintains system related documentation (procedures, events, etc.) with the appropriate applications (Docspace, Trackwise, ClearQuest, HP-ALM or any other designed system
• Participates in system related project activities as requested by the CoE lead including review and testing of system updates
• Coordinates eLIMS activities with the local labs
• Updates eLIMS instrument master data, eLIMS Empower master data, eLIMS LES master data, and uploads Smart QC Master Data
• Creates test scripts for user acceptance testing, and executes user acceptance testing using customized test scripts from the local labs
• Participates in capability development activities according to training requirements
• Provides feedback to the CoE team lead regarding eLIMS activities performance
• 5 % – Provide feedback to CoE team lead regarding eLIMS activities performance

Experience:

• A minimum Bachelor’s Degree or equivalent education is required.
• The Analyst must have 3 – 5 years of experience.
• Knowledge & experience with LIMS is required.
• They must have the ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate.
• They must have broad knowledge and experience with cGMPs, regulations, risk management.
• Previous Quality Systems experience is required.
• Knowledge of/familiarity with other appropriate Lab systems (Empower/SDMS/LES) is preferred.
• The Analyst must have decent written and verbal communication skills (Basic in English – B2).
• They must have experience working in a pharmaceutical or other highly regulated industry.
• Experience with quality assurance, quality control, analytical testing, or IT is preferred.
• They must have the ability to maintain a strong relationship with Local Labs and maintain a clear line of communication with the eLIMS CoE lead.