QAO Specialist II
- CSL Behring
- Kankakee, Illinois
- Start date
- Mar 20, 2023
- Quality, Quality Assurance
- Required Education
- Bachelors Degree
- Position Type
- Full time
- BioMidwest, Best Places to Work
Position Purpose: Provide an overview of the responsibilities of the position by providing a summary of the most important aspects and duties of the position.
Responsible for investigating deviations. Responsible for ensuring deviation investigations are complete, accurate and drive continuous improvement on production floor to ensure compliance to cGMPs. Responsible for release of critical intermediates, relevant to area of responsibility.
- Role that this position reports to: Group Lead QAO or Manager QAO
- Role/s that report to this position: N/A
Main Responsibilities and Accountabilities:
List the roles and responsibilities of the position
- Responsible for investigating deviations, relevant to area of responsibility.
- Responsible for facilitating root cause and CAPA discussion with responsible department and any required support group(s).
- Responsible for coordinating necessary research to determine root cause, corrective/preventative actions and product disposition, and utilizing investigation tools provided by QAO Management.
- Responsible for performing complete and accurate deviation investigations in accordance with site procedures/metrics while meeting DIFOT timelines.
- 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.
- Responsible for area audits appropriate to area of responsibility, and working with manufacturing personnel to resolve issues real-time.
- Assist in regulatory inspections as requested by management.
- As appropriate to area of responsibility, perform critical intermediate releases.
- 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.
Position Qualifications and Experience Requirements:
Provide hiring requirements for the specified position, including educational, experiential, and competency requirements necessary for the position.
B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).
Two or more 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 required. Or in lieu, proven ability to perform in this role will be considered.
Time Management – uses time effectively and efficiently, concentrates efforts on the more important priorities.
Informing – provides information so accurate decisions can be made.
Composure – is able to work under pressure, handle tough situations and remain focused.
Presentation Skills - is effective in a variety of formal presentation settings, can manage group process during the presentation
Written Communications – is able to write clearly in a variety of communication settings and styles, can get messages across.
Decision Quality – makes good decisions based on analysis and judgment, sought out by others for advice and solutions
Problem Solving – uses logic and methods to solve difficult problems with effective solutions
Creativity – comes up with new and unique ideas, easily makes connections among previously unrelated notions.
Functional/ Technical Skills; specifically must have working knowledge of cGMPs and FDA guidelines.
Knowledge of the Quality System (TrackWise) that support deviation investigations, and CAPA a plus.About Us
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!
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
1020 First Avenue
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