Quality Systems Associate

Quality Systems Associate The Quality Systems Associate works under the direct supervision of the Quality Systems Manager to perform quality assurance and training functions to ensure compliance with internal and external regulations and protocols. Responsibilities Complete weekly review of equipment QC and maintenance records. Document, investigate, and conduct root‑cause analysis for deviations and customer complaints related to product quality and donor safety. Inspect and release incoming supplies; investigate and report supplies that do not meet specifications before use. Review documentation for unsuitable test results. Assist the Manager in ensuring cGMP regulations, SOPs, and regulatory requirements are followed. Perform all product release activities. Review lookback information and documentation. Review waste shipment documentation. Review unexpected plasmapheresis events, including electronic donor chart exceptions impacting donor eligibility, safety, or product quality. Review donor deferral notifications from competitor centers. Review plasma processing documentation to ensure proper freezing, storage, and handling. Ensure center training programs follow procedural requirements defined in the donor center SOP. Create, maintain, and audit training records and files to ensure compliance. Perform employee training observations to confirm staff competency before independent work. Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations. When the Manager is absent, review and approve deferred donor reinstatement activities and assist in completing internal donor center audits. Review monthly trending reports. Review donor adverse events reports and related documentation. Conduct training to address donor center corrective and preventative measures. Additional Responsibilities Maintain certification as a Donor Center Technician. Qualifications High school diploma or GED; obtain required state licensures or certifications. Proficiency with computers and basic document review. Strong integrity, commitment to quality and compliance, and ability to follow SOPs and regulations. Effective interpersonal and organizational communication and problem‑solving skills. Basic understanding of FDA regulations and cGMP. Good knowledge of mathematics and legible handwriting. Ability to work flexible schedules, spend extended periods reviewing documentation, and maintain attention to detail. Ability to handle basic training observations and staff competency assessments. Experience No previous related experience required. Occupational Demands Work is performed in a plasma center with exposure to biological fluids, electrical equipment, and extreme cold. The position requires frequent hand, foot, and neck movements; light lifting up to 50 lbs.; hearing acuity; and vision requirements. Compensation and Benefits The estimated pay scale for this role based in Colorado Springs, CO, is $20.40–$27.60 per hour, with eligibility for up to 5 % of the company bonus pool. Benefits include medical, dental, vision, life insurance, PTO, paid holidays, a 401(k) match of up to 5 %, and tuition reimbursement. Location Colorado Springs, CO. North America: USA – Colorado Springs. Equal Employment Opportunity Statement Grifols provides equal employment opportunities to applicants and employees without regard to race, color, sex, gender identity, sexual orientation, religious practices and observances, national origin, pregnancy, childbirth or related medical conditions, protected veteran status, or disability. We will consider all qualified applicants in a manner consistent with applicable laws. #J-18808-Ljbffr