The role 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. Independently coordinates local projects and supports the realization of global projects and process improvement initiatives.

　　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

　　Responsibilities:

　　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 requesting business unit and the development team.

　　Ensure a 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.

　　Other duties and responsibilities as assigned by senior management.

　　Qualifications:

　　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 and at least 1 year experience in LIMS maintenance, support and project activities.

　　Our Benefits

　　CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

　　Please take the time to review our benefits site (https://www.cslbenefits.com/csl/candidates) to see what’s available to you as a CSL employee.

　　About CSL Behring

　　CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring (https://www.cslbehring.com/our-company) .

　　We want CSL to reflect the world around us

　　As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.

　　Do work that matters at CSL Behring!

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　　CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement