Quality Systems Associate

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Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that has been improving the health and well‑being of people worldwide since 1909. We are leaders in plasma‑derived medicines and transfusion medicine and produce innovative medicines, solutions, and services in more than 110 countries.

Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols.

• Complete weekly reviews of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that have not met quality specifications before use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation, waste shipment documentation, and unexpected plasmapheresis events, including electronic donor chart and related documentation.
• Review electronic donor chart exceptions impacting donor eligibility/safety or product quality, and donor deferral notifications from competitor centers.
• Review plasma processing documentation to ensure proper freezing, storage, and handling of product.

• Assist the Quality Systems Manager to ensure center training programs follow procedural requirements defined in the donor center SOP and training documents.
• Create, maintain, and audit training records 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.
• If the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.

• Perform review of monthly trending reports.
• Perform review of donor adverse events reports and applicable documentation.
• Conduct training to address donor center corrective and preventative measures.

• Strong interpersonal communication, organizational, and problem‑solving skills.
• Understanding of FDA regulations, cGMP and quality systems.
• Integrity, commitment to quality, and compliance.
• Basic mathematics and legible handwriting.
• Proficiency with computers.
• Ability to work flexible scheduling to meet business needs.
• Perform basic document review and employee observations.
• Communicate openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Spend hours sitting and reviewing documentation for accuracy.
• Demonstrate organizational skills and attention to detail.

High school diploma or GED. Obtain state licensures or certifications if applicable.

Typically requires no previous related experience.

Work is performed in a plasma center with exposure to biological fluids, electrical office and laboratory equipment, and extreme cold below 32°F while reviewing documents in plasma freezers. Personal protective equipment is required. Work is mostly sitting for 4‑6 hours per day, standing 2‑4 hours, bending and twisting at the neck 2‑4 hours, frequent hand movements, and light lifting up to 50 lbs.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices, national origin, pregnancy, childbirth, or related medical conditions, status as a protected veteran or spouse/family member of a protected veteran, or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws.

North America: USA: NE‑Lincoln: BTLNN – Lincoln NE – 17th St – BPC

Req  
• Type:
Regular Full‑Time
• Category:
Manufacturing

Full‑time
• Entry level

Information Technology
• IT Services and IT Consulting