QAO Specialist II

Job Description

Responsibilities:

• Responsible for initiating deviations, relevant to area of responsibility.
• Responsible for facilitating root cause and CAPA discussion with the 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 initial 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 a 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 the investigation and  GMP changes to production personnel.
• Drive continuous improvement on the production floor to ensure compliance with cGMPs. 
• Responsible for area audits appropriate to the area of responsibility, and working with manufacturing personnel to resolve issues in real time.
• Assist in regulatory inspections as requested by management.
• As appropriate to the area of responsibility, perform critical intermediate releases.
• Flexible to work Night Shift 9PM-5AM.

Education:

• B.A. or B.S. degree preferably in a scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).

Experience:

• Two or more years of 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 required. Or in lieu, a proven ability to perform in this role will be considered.
• Knowledge of the Quality Systems (TrackWise and Veeva) that support deviation investigations, and CAPA is 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.