Quality Systems Associate

About the role

Grifols is a global healthcare company dedicated to improving the health and well-being of people worldwide. As a Quality Systems Associate, you will play a crucial role in ensuring compliance with internal and external regulations and protocols.

Responsibilities

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they relate to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies that do not meet quality specifications and requirements before use.
• Performs documentation review for unsuitable test results.
• Aids the Quality Systems Manager in ensuring adherence to cGMP regulations, SOPs, and regulatory requirements. Duties include:
• Performing all product release activities.
• Reviewing lookback information and documentation.
• Reviewing waste shipment documentation.
• Reviewing unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions during the donation process.
• Reviewing electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Reviewing donor deferral notifications from competitor centers.
• Reviewing plasma processing documentation to ensure proper freezing, storage, and handling of product.
• Aid the Quality Systems Manager in ensuring center training programs comply with procedural requirements as defined in the donor center SOP and/or training program documents. Duties include:
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• Occasionally, when the Quality Systems Manager is absent, the Quality Systems Associate may assist with the following duties:
• Reviews and approves deferred donor reinstatement activities.
• Assists with completing the internal donor center audit.
• Performs review of monthly trending report.
• Performs review of donor adverse events reports and the applicable related documentation.
• Conducts training to address donor center corrective and preventative measures.

Qualifications

• High school diploma or GED.
• Obtains state licensures or certifications if applicable.
• Certified and maintains certification as a Donor Center Technician.
• Develops command of interpersonal communication, organizational, and problem-solving skills.
• Understands FDA regulations.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics.
• Legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Performs basic document review and employee observations.
• Communicates openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOP’s and protocols.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Has a basic understanding of cGMP and quality systems.
• Able to spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

Benefits

Grifols offers a comprehensive benefits package including medical, dental, vision, life insurance, paid time off, paid holidays, and up to 5% 401(K) match and tuition reimbursement. Final compensation packages will depend on education, experience, skillset, knowledge, location, internal equity, and market data.