QAO Specialist I
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Kankakee, IL 60901
QAO Specialist IUnited States of AmericaR-0824902010 CSL Behring L.L.C.
Main Responsibilities and Accountabilities:
1. Responsible for assisting with investigating deviations relevant to area of responsibility.
2. Responsible for participating in investigation meetings with responsible department and any required support group(s).
3. Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.
4. Collaborate with manufacturing personnel to perform root cause analysis at time deviation
occurs, and assist in determining robust corrective/preventive actions.
5. On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
6. 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.
7. Execute training/awareness related to investigation and GMP changes to production
8. Drive continuous improvement on production floor to ensure compliance to cGMPs.
9. As appropriate to area of responsibility, responsible for ensuring sample retain area is
maintained in a state of compliance and all annual inspections are completed in a timely
10. As appropriate to area of responsibility, perform Acceptable Quality Level (AQL)
Position Qualifications and Experience Requirements:
Education: B.A. or B.S. degree. Prefer degree to be in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).
Experience: 0-2 years experience working in a cGMP regulated environment such as the field of quality, manufacturing or engineering field, applying the cGMP rules in everyday activities. Technical writing experience is preferred.
Informing – is timely and accurate with information.
Peer Relationships – Can quickly find common ground and solve problems for the good of
all, is a team player and cooperative.
Self-Knowledge – Seeks feedback, gains insights from mistakes, is open to criticism.
Action Oriented – Enjoys working hard; is energetic for the things that he/she sees as
Written Communications – is able to write clearly in a variety of communication settings
and styles, can get messages across
Conflict Management – Steps up to conflicts, seeing them as opportunities, can find
Learning on the Fly – Open to change, learns quickly when facing new problems, versatile
Dealing with Ambiguity – Can effectively cope with change, can shift gears comfortably,
can comfortably handle risk and ambiguity.
Must demonstrate competency in verbal and written communication. TrackWise knowledge a plus.
State/Province : Illinois
City : Kankakee
Street Address : 1201 N. Kinzie
Primary Location : CSL Behring Kankakee
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click below.
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