What are the responsibilities and job description for the Regulatory Compliance Specialist position at Grifols?
What You Will Do
In this role, you will oversee the development and implementation of quality systems in our plasma donation centers. Your key responsibilities will include:
• Conducting regular quality inspections and controls to ensure center compliance with quality standards and regulations
• Collaborating with Center Managers to ensure product quality, donor suitability, and donor safety
• Developing and implementing Standard Operating Procedures (SOPs) and ensuring staff adherence
• Overseeing internal and external audits, including execution, documentation, review, and preparation of responses
• Implementing corrective and preventative actions, assessing their effectiveness, and following up as required
• Managing personnel functions, including direction, assignment of work, hiring, development, training, disciplinary actions, termination, and maintenance of personnel records
• Overseeing product and biohazard waste shipments to ensure compliance with regulatory specifications and product release requirements
• Ensuring accuracy of donor files and supplies meet quality requirements
• Directing equipment maintenance and calibration, documenting procedures, and ensuring proper storage conditions
• Monitoring CLIA proficiency test surveys, complaint investigations, and training documentation
What You Will Need
To succeed in this role, you must possess the following qualifications:
1. Bachelor of Science degree or equivalent
2. Certified and proficient in quality and compliance
3. Working towards certification from the American Society for Quality as a Certified Quality Auditor
4. Working towards certification as a Designated Trainer for quality areas
5. 2-5 years of related work experience in a medical and/or cGMP regulated environment
6. Experience with plasma or whole blood
7. Ability to understand and assess FDA regulations
8. Strong integrity and commitment to quality and compliance
9. Excellent interpersonal communication, organizational, and problem-solving abilities
10. High level of proficiency with computers and root cause analysis
Benefits
You will enjoy a comprehensive benefits package, including medical, PTO, pharmacy, dental, vision, disability insurance, life and AD&D insurance, 5% 401(k) match, and tuition reimbursement.
In this role, you will oversee the development and implementation of quality systems in our plasma donation centers. Your key responsibilities will include:
• Conducting regular quality inspections and controls to ensure center compliance with quality standards and regulations
• Collaborating with Center Managers to ensure product quality, donor suitability, and donor safety
• Developing and implementing Standard Operating Procedures (SOPs) and ensuring staff adherence
• Overseeing internal and external audits, including execution, documentation, review, and preparation of responses
• Implementing corrective and preventative actions, assessing their effectiveness, and following up as required
• Managing personnel functions, including direction, assignment of work, hiring, development, training, disciplinary actions, termination, and maintenance of personnel records
• Overseeing product and biohazard waste shipments to ensure compliance with regulatory specifications and product release requirements
• Ensuring accuracy of donor files and supplies meet quality requirements
• Directing equipment maintenance and calibration, documenting procedures, and ensuring proper storage conditions
• Monitoring CLIA proficiency test surveys, complaint investigations, and training documentation
What You Will Need
To succeed in this role, you must possess the following qualifications:
1. Bachelor of Science degree or equivalent
2. Certified and proficient in quality and compliance
3. Working towards certification from the American Society for Quality as a Certified Quality Auditor
4. Working towards certification as a Designated Trainer for quality areas
5. 2-5 years of related work experience in a medical and/or cGMP regulated environment
6. Experience with plasma or whole blood
7. Ability to understand and assess FDA regulations
8. Strong integrity and commitment to quality and compliance
9. Excellent interpersonal communication, organizational, and problem-solving abilities
10. High level of proficiency with computers and root cause analysis
Benefits
You will enjoy a comprehensive benefits package, including medical, PTO, pharmacy, dental, vision, disability insurance, life and AD&D insurance, 5% 401(k) match, and tuition reimbursement.
