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.
More Information
- Salary Offer 0 ~ $3000
- Experience Level Junior
- Total Years Experience 0-5
- Dropdown field Option 1