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hace 2 meses
Csl Plasma Inc. is seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality team, you will play a critical role in ensuring the highest standards of quality and compliance in our operations.
Key Responsibilities- Monitor and report on compliance status data to operational quality management
- Collaborate with center management to develop and implement continuous improvement plans
- Represent the center during internal and external audits, respond to questions, and stop operations as needed to address quality concerns
- Coordinate and manage training activities, policies, and processes at the center level
- Perform final QA review and release for all shipments and associated documents to ensure compliance with customer specifications
- Maintain and review plasma center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements
- Initiate, schedule, coordinate, and monitor the delivery of all training, including new hire, annual, and retraining to meet center or other training and regulatory requirements
- Conduct periodic process assessments to ensure compliance with CSL written procedures
- Identify and communicate non-conformities to CSL's SOPs
- Promote Safety, Health, and Environment Policies & Procedures
- Conduct and lead internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations
- High school diploma or equivalent required; Associate or Bachelor's degree in business administration or biological sciences preferred
- Minimum 1-year leadership experience or equivalent of one-year experience in a regulated environment
- Strong critical reasoning, decision-making, and problem-solving skills to analyze situations
- Organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities in support of changing company objectives
- Understanding of Quality Systems and/or regulated training requirements
Occasionally required to work with the public when they are dissatisfied. 80% of the time standing and walking and 20% of the time sitting. Reach, bend, kneel, and have a high level of manual dexterity. See and speak with customers and observe equipment operation. Occasionally be required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes, working with freezers, and various odors.
