Quality Assurance Manager

5 days ago


Worcester, Massachusetts, United States Grifols Full time
Quality System Manager

Grifols is a global healthcare company that has been working to improve the health and well-being of people around the world since 1909.

We are leaders in plasma-derived medicines and transfusion medicine, developing, producing, and marketing innovative medicines, solutions, and services in over 110 countries and regions.

Key Responsibilities:
  • Maintain oversight of the center's quality management system and ensure continuous quality improvement.
  • Implement Standard Operating Procedures (SOPs) for quality control and overall regulatory compliance.
  • Maintain oversight of center training program by ensuring compliance to program requirements.
  • Collaborate with Center Manager to ensure the donor center operates in a manner that assures product quality, donor suitability, and donor safety.
  • 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, and implementation of corrective/preventative actions.
  • Continuously assesses, promotes, and improves the effectiveness of quality and training systems in the donor center.
  • Documents, investigates, and performs root-cause analysis for deviations and customer complaints.
  • Ensures shipments meet regulatory specifications and product release requirements.
Requirements:
  • Bachelor of Science degree or equivalent.
  • Typically requires 2 years of related experience in a medical and/or cGMP regulated environment.
  • Strong integrity and commitment to quality and compliance.
  • High level of proficiency with computers.
  • Proficient in root cause analysis and corrective/preventative actions.
  • Strong time management abilities.
What We Offer:
  • Medical, PTO, up to 5% 401K match, and tuition reimbursement.
  • A family-like culture with a global presence in 30 countries.

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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