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QAO Specialist I

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Job Details
Job Order Number
Company Name
CSL Behring
Physical Address

Kankakee, IL 60901
Job Description

QAO Specialist IUnited States of AmericaR-0824902010 CSL Behring L.L.C.

Job Description

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

common ground.

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.

Additional Comments:

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.

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