eLIMS Master Data Analyst (HYBRID)

Requirements:

• Role is HYBRID (3 days onsite)

• Candidates can be local to Titusville, NJ; Horsham, PA; or Wilson, NC (must be able to commute for HYBRID)

• NO additional travel needed for this role

• Bachelor's degree

• Candidates need to be familiar with building a system from the bottom to the top

• eLIMS system implementation is the bulk of the role

• Need to have experience with automation to help with automation of eLIMS (Electronic Laboratory Information Management System) setup

• Must have Master Data experience (back-end experience), building the system experience not user experience

• Experience with TruVault, COMET, Confluence

• Must have experience with Analytical Testing

• Will be working with others in different countries

• Will train with a group in India in the mornings

• Must be willing to be on "camera" for meetings

• Experience with laboratory systems

• Should have 4-6 years of experience

Qualifications

• A minimum bachelor's degree or equivalent education is required. A minimum of 4 6 years of working experience in a regulated medical industry (Pharmaceutical, Medical Devices, or Diagnostics) with knowledge and experience with LIMS and Quality Systems is required.
• Extensive other experience with analytical testing, quality control or IT is preferred.
• Ability to manage multiple issues, organize activities, prioritize, and escalate to management when appropriate. Broad knowledge and experience with cGMPs, applicable regulations (e.g., FDA, ICH Q8, 9, 10), and risk management
• Demonstrated strong written and verbal communication skills (Basic in English B2) and the ability to develop and provide training to colleagues and partners.
• Demonstrates flexibility in adapting to urgent needs.
• Ability to interact with local lab leaders on master data related issues as needed and maintain a strong relationship with local laboratories.
• Maintain a clear line of communication with the eLIMS CoE lead.
• High level commitment to meeting customer expectations as determined by the eLIMS CoE lead

Description: Principle responsibilities:

• This position works within the eLIMS (Electronic Laboratory Information Management System) CoE and is an expert in data setups in the eLIMS system to support lab processes including paperless, product release and CofA generations.
• Additionally, this position will support an implementation of the LIMS LabVantage (eLIMS) system at a new plant based in North Carolina.
• This position independently maintains and reviews high quality data setups, integrates instruments and applications and translates specifications within the eLIMS system using current business processes.
• This position reviews and tests system updates, creates and manages any system related documents, and identifies and drives process improvements.
• This position is able to interact with IT and speaks business language to customers.
• This position takes ownership by completing any incoming requests in a timely manner. In order to maintain high quality data.
• This position is expected to fully understand the sites master data requirements and lab processes to ensure all configurations are accurate and complete.
• This position is responsible and able to lead projects within QC Operations, e.g. implementation of paperless processes, harmonization / standardization of processes.
• Candidate to work with multiple stakeholders to provide input and ensure end to end set up of eLIMS master data to support implementation.
• Maintains system related documentation (procedures, events, etc) with the appropriate applications (TruVault, COMET, Confluence, q-Test or any other designed system;