QAO Specialist

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Hours for this position are 10:00 PM – 6:00 AM

This is an entry‑level position into Quality Assurance Operations. The core duties include assisting with investigating deviations, monitoring real‑time batch records, and driving continuous improvement on the production floor to ensure compliance with cGMPs.

• Assist with investigating deviations relevant to the area of responsibility and participate in investigation meetings with the responsible department and support groups.
• Conduct research to determine root causes, corrective/preventive actions, product disposition, and use investigation tools provided by QAO Management.
• Collaborate with manufacturing personnel to perform root cause analysis when a deviation occurs and aid in determining robust corrective/preventive actions.
• Be on‑call for immediate inspections, investigations, and reviews of potential GMP‑related issues, providing quality assessment of possible deviations.
• Review critical in‑process steps in real time (e.g., viral reduction/sterility assurance), approve completed production records, and notify manufacturing personnel of facility/process/equipment/documentation issues.
• Drive continuous improvement on the production floor to ensure compliance with cGMPs.
• Execute training/awareness on investigation and GMP changes for production personnel.
• Perform Acceptable Quality Level (AQL) assessments as appropriate to the area of responsibility.

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

• 0–2 years’ experience working in a cGMP‑regulated environment (quality, manufacturing, or engineering) applying cGMP rules in everyday activities.
• Technical writing experience is preferred.
• Proficiency with Microsoft Office.
• Proficiency in QA systems is preferred.

The expected wage range for this position at hiring is $22.60/hour – $26.00/hour. Individual base pay will be determined by qualifications, skill level, experience, competencies, and other relevant factors.

CSL employees who work at least 30 hours per week are eligible for benefits effective on day 1. CSL offers a range of resources, including health care and financial protection, to support employees at every life stage. For more details, please visit our benefits site.

CSL Behring is a global biotherapeutics leader focused on saving lives. We discover, develop, and deliver innovative therapies across multiple therapeutic areas, supporting patients with unmet medical needs. CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma, and is a subsidiary of CSL headquartered in Melbourne, Australia, employing 32,000 people worldwide.

At CSL, inclusion and belonging are at the core of our mission. We aim to build a diverse workforce and foster a culture of curiosity, empathy, and innovation.