QAO (Quality Assurance Operations) Specialist I

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 QAO (Quality Assurance Operations) Specialist l

Must be available to work 8 hour/5 day or 12 hour/7 day schedule.

QAO Specialist 1 - Purpose:

This is an entry level position into Quality Assurance Operations. Developing responsibilities include assisting with investigating deviations, relevant to area of responsibility. Responsible for driving continuous improvement on production floor to ensure compliance to cGMPs. Real time review of batch records, including critical processing steps with production floor presence.

Responsibilities:

• Responsible for assisting with investigating deviations relevant to area of responsibility. Responsible for participating in investigation meetings with responsible department and any required support groups.
• Responsible for participating in necessary research to determine root cause, corrective/preventative actions, product disposition, and using the investigation tools provided by QAO Management.
• Collaborate with manufacturing personnel to perform root cause analysis at time deviation occurs, and assist in determining robust corrective/preventive actions.
• On-call for immediate inspections, investigations, and review of possible GMP related issues and ability to provide quality assessment of potential deviation.
• 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.
• Execute training/awareness related to investigation and GMP changes to production personnel.
• Drive continuous improvement on production floor to ensure compliance to cGMPs.
• 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 manner.
• As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.

Education:

• B.A. or B.S. degree preferably 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.

Competencies:

• 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.
• Action Oriented - Enjoys working hard; is energetic for the things that he/she sees as challenging.
• 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 learner.
• Must demonstrate competency in verbal and written communication. TrackWise knowledge a plus.

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.

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.

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.