Lab Data Associate
Less than 5 years experience • Biotech/Pharma
· The Analyst, LIMS Master Data Associate, Lab Systems works within the eLIMS CoE, and independently creates, updates and maintains high quality Master Data within eLIMS, integrates instruments and applications with eLIMS, performs user acceptance testing and translates specifications within the eLIMS system by utilizing current business processes.
· The Analyst takes ownership when completing incoming requests in a timely manner. They will immediately escalate any issues and understand the impact towards 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 their requirements and will review all configurations for accuracy and completeness.
Major Duties and Responsibilities:
· Creates, updates, reviews & approves Master Data (release and stability) including worksheet templates, worklist templates and sample plans
· 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 CoE team lead regarding eLIMS activities performance
· Provide feedback to CoE team lead regarding eLIMS activities performance
Education & Experience Requirements:
· A minimum Bachelor's degree or equivalent education is required.
· The Analyst must have 0 – 2 years experience.
· Knowledge & experience with LIMS is preferred.
· They must have the ability to manage multiple issues, organize activities, prioritize and escalate to management when appropriate.
· They should have broad knowledge and experience with cGMPs, regulations, risk management.
· Previous Quality Systems experience is desirable.
· Knowledge of/familiarity with other appropriate lab systems (Empower/SDMS/LES) is preferred.
· The Analyst must have decent written and verbal communication skills
· They should have experience working in a pharmaceutical or other highly regulated industry.
· Experience with quality assurance, quality control, analytical testing or IT is preferred.
· The Analyst must be flexible to adapt to urgent needs.
· They must have the ability to interact with Local lab leaders where necessary regarding master data related issues.
· 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.