Quality Assurance Specialist
6 days ago
This is an exciting opportunity to join CSL as a Quality Assurance Specialist, providing critical support to the Assistant Manager of Quality in ensuring overall compliance with CSL Operating Procedures and regulatory requirements.
Key Responsibilities- Monitor plasma center processes to ensure compliance with CSL Operating Procedures and regulatory requirements.
- Report 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.
- Ensure center records are thoroughly reviewed, accurate, and timely, and initiate investigations and documentation of regulatory deficiencies.
- Maintain and review plasma center personnel training documents to ensure compliance with CSL procedures, SOPs, CLIA/COLA, and other applicable requirements.
- Manage the Learning Management System to ensure data integrity, report generation, and data analysis comply with company and regulatory standards.
- Initiate, coordinate, and monitor the delivery of all training, including new hire, annual, and retraining, to meet center or other training and regulatory requirements.
- Collaborate with center management to identify, coordinate, and deliver retraining to correct or improve operational or quality issues.
- Conduct periodic process assessments to ensure compliance with CSL written procedures and initiate investigations to document deficiencies and develop corrective action plans.
- Identify and communicate non-conformities to CSL's SOPs and conduct internal audits to monitor facility compliance with CSL procedures and policies, cGMP, OSHA, FDA, and other regulations.
- Responsible for initiating, investigating, and closing Trackwise reports in a timely manner and confirming through follow-up that appropriate corrective action was initiated, implemented, and effective.
- 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 in a regulated environment.
- Strong customer service skills, critical reasoning, decision-making, and problem-solving skills.
- Organizational skills and attention to detail to handle multiple tasks, short deadlines, frequent interruptions, and shifting priorities.
- Understanding of Quality Systems and/or regulated training requirements.
This role requires occasional work with the public, standing and walking 80% of the time, and sitting 20% of the time. Reach, bend, kneel, and have high-level manual dexterity. See and speak with customers and observe equipment operation. Occasionally required to lift and carry 25 lbs. Exposure to hot and cold temperatures, sudden temperature changes, working with freezers, and various odors.
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