Sr. QAO Specialist
- Employer
- CSL Behring
- Location
- Kankakee, Illinois
- Start date
- Nov 27, 2021
View more
- Discipline
- Quality, Quality Assurance, Quality Control
- Required Education
- Bachelors Degree
- Position Type
- Full time
- Hotbed
- BioMidwest
Job Details
Responsibilities:
• Under general supervision, maintains Quality Assurance System to ensure compliance with company and cGMP standards
• Responsible for maintaining audit program, reviewing functional and release documentation and investigating deviations relevant to area of responsibility
• Reviews lot release documentation and facilitates compliant release process for corresponding market
• Responds to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Ensures standard operating procedures (SOP’s) stay current and align with corporate and regulatory requirements
• Executes training/awareness related to GMP standards
Qualifications:
• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated 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 educational requirements. Refer to local job documentation where applicable.
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
- Phone
- 610-878-4000
- Location
-
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States
Get job alerts
Create a job alert and receive personalized job recommendations straight to your inbox.
Create alert