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Quality Assurance Systems Specialist
2 months ago
About Grifols:
Grifols is a leading global healthcare organization dedicated to enhancing the health and well-being of individuals worldwide. Established in 1909, we specialize in plasma-derived therapies and transfusion medicine, providing innovative solutions and services across more than 110 countries.
Position Overview:
Under the guidance of the Quality Systems Manager, the Quality Systems Associate is responsible for executing quality assurance and training functions to guarantee adherence to both internal and external regulations and protocols.
Key Responsibilities:
- Conduct weekly assessments of equipment quality control and maintenance documentation.
- Document, investigate, and analyze root causes for deviations and customer complaints, particularly concerning product quality and donor safety.
- Inspect and authorize incoming supplies, ensuring they meet quality standards before utilization.
- Review documentation for any unsuitable test outcomes.
- Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, standard operating procedures (SOPs), and regulatory requirements.
- Oversee all product release processes.
- Examine lookback information and related documentation.
- Review waste shipment records.
- Assess unexpected plasmapheresis events and related documentation.
- Evaluate donor eligibility and safety through electronic donor chart reviews.
- Review notifications regarding donor deferrals from competitor centers.
- Ensure proper documentation for plasma processing, including freezing, storage, and handling.
Training Responsibilities:
- Support the Quality Systems Manager in maintaining training programs in accordance with procedural requirements outlined in the donor center SOP and training documents.
- Create, maintain, and audit training records to ensure compliance.
- Conduct employee training observations to verify staff competency before allowing independent work.
- Facilitate necessary training for Center Notifications, Corporate Directives, SOP updates, and initial SOP implementations.
Additional Duties:
- In the absence of the Quality Systems Manager, the Quality Systems Associate may review and approve deferred donor reinstatement activities.
- Assist in the completion of internal donor center audits.
Qualifications:
- High school diploma or GED required; state licensures or certifications may be necessary.
- Developing skills in interpersonal communication, organizational abilities, and problem-solving.
- Understanding of FDA regulations and commitment to quality and compliance.
- Basic knowledge of mathematics and proficiency with computers.
- Ability to work flexible hours to meet business needs.
Work Environment:
This role is performed in a plasma center, with potential exposure to biological fluids and infectious organisms. Personal protective equipment is mandatory. The position requires sitting for extended periods, standing, and occasional light lifting.
Grifols is an equal opportunity employer, committed to diversity and inclusion in the workplace.
