Quality Systems Associate

Quality Systems Associate Under the direct supervision of the Quality Systems Manager, perform quality assurance and training functions to ensure compliance with internal and external regulations and protocol. Responsibilities Complete weekly review of equipment QC and maintenance records. Document, investigate, and perform 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 quality specifications. Review documentation for unsuitable test results. Assist the Quality Systems Manager to ensure that 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 charts and related documentation. Review electronic donor chart exceptions impacting donor eligibility, safety, and product quality. Review donor deferral notifications from competitor centers. Review plasma processing documentation to ensure proper freezing, storage, and handling of product. Assist with training programs: create, maintain, and audit training records; perform employee training observations; conduct required training activities for center notifications, corporate directives, SOP changes, and initial SOP implementations. Edit to perform additional duties when the Quality Systems Manager is absent, such as reviewing and approving deferred donor reinstatement activities and assisting with the internal donor center audit. Perform review of monthly trending reports. Perform review of donor adverse events reports and related documentation. Conduct training to address donor center corrective and preventative measures. Maintain certification as a Donor Center Technician. Knowledge, Skills, and Abilities Developing command of interpersonal communication, organizational, and problem‑solving skills. Strong integrity and commitment to quality and compliance. Good knowledge of mathematics and legible handwriting. Proficiency with computers. Ability to work flexible schedules to meet business needs. Perform basic document review and employee observations. Communicate openly with the CQM on issues noted during reviews. Understand and follow FDA regulations, SOPs, and protocols. Perform primary responsibilities of the Quality Associate role proficiently. Basic understanding of cGMP and quality systems. Spend hours sitting and reviewing documentation for accuracy. Demonstrate good organizational skills and attention to detail. Education High school diploma or GED. Obtains state licensure or certification if applicable. Experience Typically requires no previous related experience. Occupational Demands Work performed in a plasma center; exposure to biological fluids and potential infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32°F while performing reviews in plasma freezers. Personal protective equipment required: protective eyewear, garments, gloves, and cold gear. Sitting for up to 4–6 hours per day, standing 2–4 hours per day. Bending and twisting of the neck 2–4 hours per day; frequent hand movements; precise coordinated finger movements; foot movement; occasional walking, bending, and twisting at waist. Light lifting up to 15 lb. with a maximum lift of 50 lb.; may reach below shoulder height. Hearing acuity essential; color perception and vision (corrected 20/30 in one eye, 20/100 in the other) necessary. Ability to communicate information and ideas clearly. Work independently with minimal guidance. Perform a wide range of tasks as dictated by variable demands and changing conditions. Relate sensitive information to diverse groups. 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, veteran status, or disability. We will consider for employment all qualified applicants in a manner consistent with the requirements of all applicable laws. Location NORTH AMERICA : USA : AL-Hueytown:USHUE - Hueytown AL-Forest Rd #J-18808-Ljbffr