Scientist QCE LIMS

The QCE LIMS Scientist is a subject matter expert on laboratory information management systems (LIMS) and performs dynamic and static data changes in LIMS within the operations team under direction of the Head QCE LIMS or delegate. The QCE LIMS Scientist independently coordinates local projects and supports the realization of global projects and process improvement initiatives.

Responsibilities

• Ensuring actions comply with: -CSL’s Code of Responsible Business Practice -CSL’s Global Quality Policy -Site’s Quality Manual -Current Good Manufacturing Practice as applicable to this role -CSL’s Health, Safety & Environment Management System

• Stay current with cGMP training as required to maintain compliance with CSL quality and regulatory commitments.
• Follow CSL documentation and data integrity requirements associated with generation and reporting of cGMP activities.
• Perform, review and document dynamic and static data changes in LIMS as per business request.
• Lead the development of LIMS calculations in close collaboration with requestors.
• Coordinate the implementation of local changes and projects and act as a subject matter expert for LIMS related topics.
• Support the realization of global projects in close collaboration with the QCE LIMS teams and stakeholders of other sites.
• Timely prepare, review, and update standard operating procedures and associated documentation.
• Provide 1st and 2nd level support for LIMS users and LIMS data consumers. Coordinate and perform troubleshooting in relation to LIMS applications with multiple stakeholders involved (QC operations, Site QA, LES).
• Maintain strong relationship with the Lab Executions Systems (LES) business unit to ensure seamless 3rd level support handshake.
• Support LES in the development of new system functionalities by acting as a mediator between the requested business unit and the development team.
• Ensure pro-active and direct communication to key business units (Production Scheduling Planning, Manufacturing, QC Laboratories, QC Operational Support, Product Release) for lead time adherence and on time product release.
• Support the development and implementation of QC Excellence internal systems and tools for process and data improvements.
• Support the implementation of laboratory automation projects and act as the LIMS representative within the project team.
• Create and provide LIMS user classroom training for new users or new system functionalities.
• Provide colleagues with technical and scientific support on complex tasks as required on a local and global level across the network.
• Maintain strong relationship within Quality Control (operations team and QCE, QCAT teams) and with relevant stakeholders (particularly Laboratory Execution Systems) to ensure sharing of information to develop standardized global systems and strategies for process improvement.
• Proactively participate in the development and execution of individual personal and professional development plans to maintain and build knowledge and expertise.
• Support and maintain working in an equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
• Completes any other duties/responsibilities assigned by management.

• Bachelor’s degree in a relevant scientific or technical discipline (Natural Scientist, Pharmacist, Computer Scientist) or equivalent technical degree in relevant field., * Minimum of 2-5 years’ experience in cGMP Quality Control
• At least 1 year experience in LIMS maintenance, support and project activities.
• Minimum 1 year Master Data Management experience
• Strong IT background - SQL, JIRA, Jupyter Hub

Competencies

• Drives Results
• Plans and Aligns
• Manages Complexity
• Strategic Mindset
• Collaborates
• Communicates Effectively
• Data Management & Integrity
• Laboratory Domain Knowledge
• Quality Mindset & Compliance Culture
• Problem Solving & Troubleshooting

The expected base salary range for this position at hiring is $68,000 -78,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensationfor this role may also include incentive compensation and equity.