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Investigation Owner

Employer
CSL Behring
Location
Kankakee, Illinois
Start date
Nov 14, 2022
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Job Details

Job Description

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.

Education:

  • University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)

Qualifications:

  • 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

About Us

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 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!

Company

As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 


CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 


CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.


CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Find Us
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
US
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