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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at BioLife Plasma Services. As a Quality Assurance Specialist, you will be responsible for ensuring that our plasma collection center operates in compliance with federal, state, and local regulations, as well as company-specific policies and procedures.
Key Responsibilities- Monitor and review operational records to ensure compliance with cGMP requirements
- Track deviations and trending in operating procedures and policies
- Conduct monthly quality assurance audits for critical control points and key elements
- Collaborate with center management teams to prepare for and host internal auditors and external inspectors
- Develop and implement corrective actions for errors and deficiencies
- Minimum of one year of relevant work experience in a medical or regulated field
- Previous work experience in the plasma collection industry is highly desirable
- Computer skills in word processing, excel, data analysis, and databases are highly desirable
- Demonstrated understanding of quality assurance in an FDA-regulated environment
- Demonstrated understanding of plasma center operations
- Competitive salary range: $60,000 - $83,600
- Short-term and long-term incentives
- Medical, dental, vision insurance
- 401(k) plan and company match
- Short-term and long-term disability coverage
- Basic life insurance
- Tuition reimbursement program
- Paid volunteer time off
- Company holidays
- Well-being benefits
BioLife Plasma Services is a subsidiary of Takeda Pharmaceutical Company Ltd. We are committed to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.