Quality Systems Manager for Plasma Center

Grifols SA • Pocatello, ID

73d

About The Position

Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. This position is eligible for a $5,000 Sign-on Bonus and Relocation Assistance! As a QUALITY SYSTEMS MANAGER, you will evaluate processes, develop action plans, and coordinate the strategic implementation of system processes and corrective actions at the plasma donor center. You will report to the Regional Quality Manager.

Requirements

• Bachelor of Science degree or equivalent.
• Certified and proficient in quality and compliance.
• Typically requires 2-5 years of related experience in a medical and/or cGMP regulated environment.
• Experience with plasma or whole blood.

Nice To Haves

• Command of interpersonal communication, organizational and problem-solving abilities.
• Ability to understand and assess FDA regulations.
• Strong integrity and commitment to quality and compliance.
• High level of proficiency with computers.
• Proficient in root cause analysis and corrective/preventative actions.
• Ability to balance multiple competing priorities.
• Strong time management abilities.

Responsibilities

• Maintains oversight of the center's quality management system and ensures continuous quality improvement.
• Directs and monitors processes and ensures center compliance with all applicable state, federal, and company-designated regulations.
• Implements Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
• Collaborates with Center Manager to ensure product quality, donor suitability, and donor safety.
• Responsible for personnel functions of the Quality Systems Associate including direction, assignment of work, hiring, development and training.
• Oversees all aspects of internal and external audits including audit preparation, execution, response, and implementation of corrective actions.
• Continuously assesses, promotes, and improves the effectiveness of the quality and training systems.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
• Investigates identified trends and performs follow-up on corrective and preventive actions.
• Oversees product and biohazard waste shipments ensuring compliance with regulatory specifications.
• Performs a review of the documentation of unsuitable test results and unit lookback information.
• Ensures that job and center annual training is completed, documented, and on file.
• Performs employee training observations to ensure staff competency.
• Ensures that all supplies and materials ordered meet quality requirements.
• Determines donor suitability activities and manages donor deferrals.
• Prepares quality analysis reports to track issues and set goals.
• Ensures that CLIA proficiency test surveys, complaint investigations, and training have been properly documented.
• Holds monthly Quality Meeting to communicate status updates and manage action outcomes.

Benefits

• Full healthcare benefits
• Tuition reimbursement
• $5,000 Sign-on Bonus
• Relocation Assistance

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Merchant Wholesalers, Nondurable Goods
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees