Quality Assurance Specialist 1

This is an entry-level position in Quality Assurance Operations, focusing on real-time production floor monitoring and documentation review.

Responsibilities

• Real-time review of critical in-process steps, review/approval of completed production records, and immediate notification to manufacturing personnel regarding facility, process, equipment, or documentation issues.
• Floor monitoring for process adherence, safety, and quality issues, reporting findings through the eQMS or department/Quality escalations as appropriate.
• Participation in investigation meetings to determine root cause, corrective/preventative actions, and product disposition.
• On-call for immediate inspections, investigations, and review of potential GMP-related issues, providing quality assessments of deviations.
• Execution of training/awareness related to investigation and GMP changes for production personnel.
• Support for continuous improvement on the production floor to ensure compliance with cGMPs.
• Performance of Acceptable Quality Level (AQL) assessments as appropriate to the area of responsibility.
• Compliance with CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements.
• Provision of deviation awareness training to department personnel.

Requirements

• 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 of experience working in a cGMP-regulated environment (e.g., quality, manufacturing, or engineering).
• Proficiency in Microsoft Office and QA systems.
• Technical writing experience preferred.
• Knowledge of cGMP standards preferred.

Pay

The expected wage range for this position at hiring is $22.60/hour – $29.33/hour. Individual base pay is determined by qualifications, skill level, experience, competencies, and other relevant factors.