QAO Specialist II

QAO Specialist IIHours for this position are 7PM - 7AMOVERVIEWResponsibilities include real time production floor monitoring. Real time review of batch records, including critical processing steps, as well as other ancillary manufacturing and support systems documentation. Assisting with investigation deviations, relevant to area of responsibility. Responsible for executing continuous improvement activities on the production floor to ensure compliance to cGMPs. Release of critical intermediates for in-house use as appropriate to assigned area of responsibility.RESPONSIBILITIES• Responsible for real-time review of critical in-process steps, review/approval of completed production records, and providing immediate notification to manufacturing personnel (e.g. supervisors/operators) regarding facility/ process /equipment /documentation issues.• Real time floor monitoring for process adherence, safety and quality issues, and reporting of any findings through the eQMS or department or Quality escalations as appropriate.• Collaborate with responsible department and any required support group(s) to help determine root cause, corrective/preventative actions, and product disposition.• On-call for immediate inspections, investigations and review of possible GMP related issues and ability to provide quality assessment of potential deviation.• Execute training/awareness related to investigation and GMP changes to production personnel.• Execute 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 internal department intermediate approvals.• As appropriate to area of responsibility, perform Acceptable Quality Level (AQL) assessments.• Provide training to department personnel.QUALIFICATIONS• B.A. or B.S. degree preferably in scientific or technical field (e.g., chemistry, biology, physics, engineering, computer science, technical writing).• 1-2 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 preferred.The expected base salary range for this position at hiring is $57,000 - $72,000. Please note this salary range reflects the minimum and maximum base pay that CSL expects to pay for this position at the listed location as of the time of this posting. Individual base salary for a successful candidate is determined by qualifications, skill level, experience, competencies and other relevant factors. In addition to base salary, total compensation for this role may also include incentive compensation and equity.Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.Our BenefitsCSL 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.About CSL BehringCSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.We want CSL to reflect the world around usAt CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.Do work that matters at CSL Behring!

Created: 2025-08-07