Quality Systems Associate

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 since 1909 has been working to improve the health and well‑being of people around the world. We are leaders in plasma‑derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Summary: 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.

• 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/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure cGMP regulation, 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 and related documentation concerning exceptions during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Review 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 donor center SOPs and training documents.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competency prior to working independently.
• Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• On an occasional basis, when 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 report.
• 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.

• Develop command of interpersonal communication, organizational and problem‑solving skills.
• Understand FDA regulations and cGMP.
• Commit to quality and compliance with high integrity.
• Good knowledge of mathematics; 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.
• Understand and follow SOPs and protocols.
• Perform primary responsibilities of the Quality Associate role proficiently.
• Spend hours reviewing documentation for accuracy; demonstrate strong organizational skills and attention to detail.

• High school diploma or GED; obtain state licensures or certifications if applicable.

• Typically requires no prior related experience.

Work is performed in a plasma center. Exposure to biological fluids with 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. Work is performed mostly while sitting for up to 4 – 6 hours per day and standing from 2 – 4 hours per day.

The position requires bending and twisting of the neck for 2 – 4 hours per day, frequent hand movements, precise coordinated finger movements; light lifting of up to 15 lb and maximum 50 lb, occasional squatting or crouching. Hearing acuity essential; color perception and vision requirements as specified. Work independently with little guidance.

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; 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: AL-Hueytown: USHUE - Hueytown AL-Forest Rd