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.

• Completing weekly review of equipment QC and maintenance records.
• Documenting, investigating, and performing root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
• Inspecting and releasing incoming supplies; investigating and reporting supplies that have not met quality specifications before use.
• Performing documentation review for unsuitable test results.
• Assisting the Quality Systems Manager to ensure cGMP regulations, SOPs and regulatory requirements are followed.
• 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.
• Reviewing electronic donor chart exceptions that impact 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.

• Assisting the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in donor center SOP and/or training program documents.
• Creating, maintaining, and auditing training records and files to ensure compliance.
• Performing employee training observations to confirm staff competency before independent work.
• Conducting required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent:
• Reviewing and approving deferred donor reinstatement activities.
• Assisting with completion of the internal donor center audit.

• Is certified and maintains certification as a Donor Center Technician.

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

Typically requires no previous related experience.

• Interpersonal communication, organization, and problem‑solving skills.
• Ability to understand 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.
• Basic document review and employee observation skills.
• Open communication with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Proficient performance of primary responsibilities of the Quality Associate role.
• Basic understanding of cGMP and quality systems.
• Ability to sit for hours and review documentation accurately.
• Good organizational skills and attention to detail.

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 such as protective eyewear, garments, gloves and cold‑gear. Work is performed mostly while sitting for up to 4 to 6 hours per day and standing from 2 to 4 hours per day.

The position requires bending and twisting of the neck, frequent hand movements, precise coordinated finger movements, and light lifting up to 50 lbs. Hearing acuity essential. Color perception and vision requirements: near vision 20/30 and far vision 20/100 in the other eye, correctable. Ability to communicate information and ideas so others will understand; to listen to and understand spoken information.

Works independently with little guidance or reliance on oral or written instructions. Performs a wide range of tasks as dictated by variable demands and changing conditions.

NORTH AMERICA : USA : TX-Houston:

USBEL - Houston TX-W Bellfort-BIO

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 qualified applicants in a manner consistent with applicable laws.