Sr. QAO Specialist

CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader, driven by that same promise to save and improve lives. We offer the broadest range of quality driven plasma-derived and recombinant therapies in our industry. We have recently been awarded America’s Best Employer by Forbes magazine.

We are seeking a Senior QAO (Quality Assurance Operations) Specialist.

Responsibilities and Accountabilities:

• Responsible for writing investigating deviations, relevant to area of responsibility.
• Responsible for organizing / leading investigations, determining root cause, actions and product disposition.
• Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs and assist in determining robust actions.
• Responsible for performing complete and accurate deviation investigations in accordance with site procedures/metrics while meeting DIFOT.
• Responsible for contact with other CSL sites when necessary for investigations and/or On -call for immediate inspections, investigations and review of possible GMP related issues and ability to provide sound quality decisions of potential impact to product.
• Responsible for real-time review of critical in-process steps (e.g. viral reduction/sterility assurance), review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/process /equipment /documentation issues.
• Execute training/awareness related to GMP changes to production personnel.
• Assist in regulatory inspections as requested by management.
• As appropriate to area of responsibility, ensure sample retain area is maintained in a state of compliance and all annual inspections are completed in a timely manner

Education

• B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).

Experience

• Five (5) or more years’ experience working in a cGMP regulated environment such as the field of quality, manufacturing, or engineering field, applying cGMP rules in everyday activities. Or in lieu, proven ability to perform in this role will be considered.
• Knowledge of the Quality System (TrackWise) that support deviation investigations, and CAPA a plus.
• Working knowledge of cGMPs and the management of Quality Systems that support deviation investigations, CAPA, and Change Management.
• Good organizational, communication, and presentation skills, effective time management skills, and able to work well under pressure.
• Possesses excellent attention to detail.

Competencies

Process Management – Able to figure out the processes necessary to get things done; knows how to organize activities; understands how to separate and combine tasks into efficient workflow.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

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.

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 at CSL.

Do work that matters at CSL Behring!