Data Analyst – Quality Systems (Contract) 925 views

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.

Analyst 2 is 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. An Analyst 2 is able to lead small projects within the CoE, e.g. Harmonization/standardization of processes.

II.Major Duties And Responsibilities

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, 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

5 % – Provide feedback to CoE team lead regarding eLIMS activities performance

Education & Experience Requirements

List Job Specific Competencies/Skills Required:

• A minimum Bachelor’s degree or equivalent education is required. The Analyst must have 3 – 5 years 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 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.
• 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. They must have a strong customer focus and be dedicated to meeting customer expectations as determined by the CoE lead.