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 plasma-derived and recombinant therapies in our industry. We have recently been awarded America’s Best Employer for 2022 by Forbes magazine thus offer an exciting opportunity to join CSL as Investigation Owner.
Responsibilities of the Investigation Owner:
• The investigation owner will lead the investigation of deviations that occur in operations. Author and manage the investigations to meet key timing commitments, with well-investigated and well-documented deviation reports.
• Determines scope, product impact, root cause and corrective actions for deviations from procedures. Proposes and implements effective CAPA to eliminate these causes.
• Develops a comprehensive understanding of the manufacturing processes followed for CSL products and the associated risk management control strategy developed to identify process risks and associated critical controls around the associate processing steps.
• Provides consistent direction and ensures timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspection through close collaboration with Manufacturing and Quality teams.
• Proficient in the use of the following methodology: 5-WHY, Fish-bone diagram, Is and Is-Not, Root Cause Analysis, Human Error Reduction.
- University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
- Three (3) + years' GMP experience in pharmaceutical/biotech or other regulated industry
- Three (3) + years of technical writing experience, writing deviations and CAPAs in the pharmaceutical/biotech industry
- Knowledge of current Good Manufacturing Practices (cGMP) principles
- Knowledge of FDA and EMA requirements Different qualifications or responsibilities may apply based on local legal and/or education
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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!