Quality Assurance Systems Specialist

1 week ago

Aurora, Colorado, United States Grifols Full time

Are you passionate about enhancing healthcare quality?

Grifols is a renowned global healthcare organization dedicated to improving health and well-being worldwide. Since its inception in 1909, Grifols has been at the forefront of developing innovative medicines and solutions in over 110 countries.

Position Overview:

Reporting directly to the Quality Systems Manager, the Quality Systems Associate is responsible for executing quality assurance and training activities to ensure adherence to both internal and external regulations.

Key Responsibilities:

● Conduct weekly assessments of equipment quality control and maintenance documentation.

● Investigate and document deviations and customer complaints, focusing on their implications for product quality and donor safety.

● Inspect and authorize incoming supplies, ensuring they meet established quality standards before use.

● Review documentation for any unsuitable test outcomes.

● Collaborate with the Quality Systems Manager to uphold cGMP regulations, standard operating procedures (SOPs), and compliance requirements. Specific duties include:

● Manage all product release processes.

● Analyze lookback information and related documentation.

● Evaluate waste shipment records.

● Review unexpected plasmapheresis events and associated documentation impacting donor eligibility and product quality.

● Assess donor deferral notifications from competing centers.

● Verify plasma processing documentation to ensure proper freezing, storage, and handling of products.

Training Responsibilities:

● Assist the Quality Systems Manager in ensuring that training programs comply with procedural requirements as outlined in the donor center SOP and training documents. Duties include:

● Develop, maintain, and audit training records to ensure compliance.

● Observe employee training sessions to confirm staff competency before allowing independent work.

● Facilitate necessary training for Center Notifications, Corporate Directives, SOP modifications, and initial SOP implementations.

Additional Duties:

In the absence of the Quality Systems Manager, the Quality Systems Associate may be required to:

● Review and approve deferred donor reinstatement activities.

● Assist in conducting internal audits of the donor center.

Performance Review:

● Analyze monthly trending reports.

● Review donor adverse event reports and relevant documentation.

● Provide training to address corrective and preventive measures within the donor center.

This job description outlines the essential functions and requirements for this position. It is not intended to be an exhaustive list of duties, as managers may assign additional responsibilities as necessary.

Qualifications:

A high school diploma or GED is required. State licensures or certifications may be necessary based on the role.

Experience:

No prior related experience is typically required.

Work Environment:

Work is conducted in a plasma center, with potential exposure to biological fluids and infectious organisms. Personal protective equipment is mandatory. The role involves extended periods of sitting and occasional standing, with light lifting requirements.

Grifols is committed to providing equal employment opportunities to all applicants and employees, regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other characteristic protected by law.

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