Analyst 3 - Quality Assurance

Description :

Principle responsibilities :

This position works within the eLIMS 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 as part of Pharmaceutical, Innovative Medicine. 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;

Qualifications

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.

bility 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.

Up to 5% Travel required

Primary Location

New Jersey, North Carolina, Pennsylvania

Other Locations

United States

Enable Skills-Based Hiring No Is this position safety sensitive? No Will this position require the handling of a controlled substance? No Hours per Day 8 Hours per Week 40 Total Hours 2,088.00