QAO Specialist I

QA Specialist l

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.

•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.

• Proficiency in Microsoft Office and QA systems

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what’s available to you as a CSL employee.

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 organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.