Quality Assurance Specialist
1 week ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at Grifols, a global healthcare company with over 110 years of experience. As a key member of our organization, you will be responsible for ensuring the quality and compliance of our products and processes.
Estimated Salary: $65,000 - $90,000 per year, depending on location and experience.
About Us
Grifols is a leading provider of plasma-derived medicines and transfusion medicine solutions, operating in over 30 countries worldwide. Our commitment to innovation and excellence has earned us a reputation as a trusted partner in the healthcare industry.
About the Role
This is an exciting opportunity to work in a fast-paced environment, where no two days are ever the same. As a Quality Assurance Specialist, you will be responsible for:
- Maintaining oversight of the center's quality management system and ensuring continuous quality improvement
- Directing and monitoring processes to ensure center compliance with all applicable state, federal, and company-designated regulations
- Collaborating with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety
- Responsible for personnel functions, including direction, assignment of work, hiring, development, and training
- Oversight of all aspects of internal and external audits, including audit preparation, execution, response, implementation of corrective/preventative actions, assessment of corrective actions, and follow-up
- Continuously assessing, promoting, and improving the effectiveness of quality and training systems in the donor center through recognition of trends, investigation of failures in the execution of procedures, and direct observations
- Documenting, investigating, and performing root-cause analysis for deviations and customer complaints
Requirements and Qualifications
To succeed in this role, you will need:
- Bachelor of Science degree or equivalent in a related field
- 2+ years of experience in a medical and/or cGMP regulated environment, preferably in plasma or whole blood production
- Strong knowledge of FDA regulations and industry standards
- Excellent communication, organizational, and problem-solving skills
- Ability to work independently with minimal supervision
Benefits
We offer a comprehensive benefits package, including:
- Medical, dental, and vision insurance
- 401(k) plan with up to 5% matching
- Tuition reimbursement program
- Ongoing training and professional development opportunities
Culture
At Grifols, we pride ourselves on our family-like culture and commitment to employee growth and development. We believe in fostering a collaborative and inclusive work environment, where everyone has the opportunity to contribute and thrive.
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