Laboratory Services Data Analyst

Janssen Supply Group, a member of Johnson & Johnson's family of Companies, is recruiting for a Laboratory Services Data Analyst. This role supports both the Raritan and Titusville NJ locations, therefore routine travel between both sites is expected.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal.  Janssen Supply Group is part of the Janssen Pharmaceutical Companies.

Are you interested in making a difference in a thriving diverse company culture, that celebrates the uniqueness of our employees and is committed to inclusion? Apply today for this exciting opportunity!

In this role the Laboratory Services Data Analyst performs the technical execution of Laboratory Services Data Analyst activities for the NJ Stability laboratory, ensuring GMP compliance, accuracy and adherence to specified project and process timelines. The Laboratory Services Data Analyst carries out duties in compliance with all local, state and federal regulations and guidelines (including FDA, EPA, DEA, OSHA, etc.) as well as all company and site policies and procedures. The Laboratory Services Data Analyst is accountable for stability lab readiness for onboarding of new lab equipment and instrumentation and performance of the required tasks associated with this onboarding (i.e. Software Validation, Equipment Qualification, Validation, Data Integrity Risk Assessments, etc). They will act as the first point of contact for issues that arise in the areas of ELM and Lab Systems space.

The Laboratory Services Data Analyst is accountable to manage and assure quality & compliance for lab equipment and instrumentation and ensure all regulatory commitments are met. They will act as a lab SME for issues that arise in the area of Equipment Lifecycle Management (ELM).

Key Responsibilities:

• Maintain data integrity standards for all lab equipment and instrumentation
• Support system upgrades, maintenance, and roll-outs of new systems, as needed
• Ensure accuracy, completeness and cGMP compliance in laboratory documentation as it pertains to Equipment Lifecycle Management
• Maintain and schedule Preventative Maintenance, Calibration and Service Calls
• Maintaining a safe work environment in compliance with all applicable environmental, health, and safety regulations
• Use Maximo software to maintain and schedule preventative / corrective maintenance, calibration and service calls  
• Interact with QC analysts to foster open dialogue regarding equipment metrology, maintenance, calibration, and repairs
• Responsible for providing analytical support on data review of equipment qualification including Installation Qualification, Operational Qualification, Performance Qualification, Preventative Maintenance and calibration documents
• Lead activities such as equipment purchase, qualification, software validation, troubleshooting, metrology, calibration and maintenance
• Responsible for creation of change controls for new or existing equipment and initiation of Quality Event Management events for equipment not meeting protocol requirements, as applicable
• Develop content for Validation Life Cycle documents like Master Validation Plan, User Requirements, Design Specification, Test Protocols (IQ/OQ/PQ), Test Summary Reports, Data Integrity Assessments, Traceability Matrix, Compliance Reports and Release Notifications for computerized systems