Quality Systems Associate

Quality Systems Associate

Grifols Shared Services North America, Inc.

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 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 have not met quality specifications 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.
• Review 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 of product.
• Assist the Quality Systems Manager with training program compliance; create, maintain and audit training records.
• Perform employee training observations to ensure staff competency.
• Conduct required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, review and approve deferred donor reinstatement activities and assist with completion of the internal donor center audit.
• Review monthly trending reports.
• Review donor adverse events reports and related documentation.
• Conduct training to address donor center corrective and preventative measures.

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

• High school diploma or GED; state licensures or certifications as applicable.
• No previous related experience typically required.
• Developing command of interpersonal communication, organizational and problem‑solving skills.
• Ability to understand FDA regulations and cGMP principles.
• 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.
• Good organizational skills and attention to detail.

• Work in a plasma center; exposure to biological fluids and infectious organisms.
• Work with 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, cold‑gear).
• Mostly sitting 4–6 hours/day; standing 2–4 hours; bending, twisting, and fine hand movements required.
• Light lifting up to 15 lbs, occasional lifting up to 50 lbs.
• Hearing and vision requirements as specified.

North America: USA: TX-Channelview: USCHANNE – Channelview TX - Sheldon Rd-BPL

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.

Req  | Type:
Regular Full-Time | Job Category:
Manufacturing

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