Quality Assurance Manager

4 days ago


Fayetteville, North Carolina, United States GRIFOLS, S.A. Full time
Job Title: Quality Assurance Manager

Grifols, a global healthcare company, is seeking a Quality Assurance Manager to join our team. As a Quality Assurance Manager, you will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:
  • Maintain oversight of the center's quality management system and ensure continuous quality improvement.
  • Direct and monitor processes to ensure center compliance with all applicable state, federal, and company-designated regulations.
  • Implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
  • Maintain and audit training records and files.
  • Collaborate with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety are maintained.
  • Responsible for the personnel functions of the Quality Associate, including direction, assignment of work, hiring, development, and training.
  • Responsible for 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 as required.
  • Continuously assesses, promotes, and improves 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.
  • Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to the safety of the donor and the quality of the product.
  • Investigates identified trends and performs follow-up on corrective and preventative actions, system implementations, and process improvement plans to measure/determine effectiveness.
Requirements:
  • Bachelor of Science degree or equivalent.
  • Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
  • Experience with plasma or whole blood.
What We Offer:
  • Medical, PTO, up to 5% 401K match, and tuition reimbursement.
  • Opportunities for professional growth and career progression.
  • A family-like culture with a commitment to quality and compliance.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic or status protected by law.



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