Quality Systems & Training Specialist

Grifols; Beaumont (TX); In loco; USD 60.000 - 80.000; Tempo pieno

Descrizione del lavoro

Grifols in Beaumont, TX is seeking a Quality Systems Associate to support quality assurance and training under the Quality Systems Manager, ensuring compliance with cGMP and regulatory protocols. You will review equipment QC, investigate deviations, release products, and maintain audit-ready documentation while supporting training programs and center operations.

The role emphasizes attention to detail, problem-solving, and adherence to SOPs, with opportunities to contribute to donor safety and

Competenze

• Developing command of interpersonal communication, organizational 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.
• Performs basic document review and employee observations.
• Communicates openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOP’s and protocols.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Has a basic understanding of cGMP and quality systems.
• Is able to spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

Mansioni

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root-cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• 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.
• Performs all product release activities.
• Reviews lookback information and documentation.
• Reviews waste shipment documentation.
• Reviews unexpected plasmapheresis events including electronic donor chart and related documentation pertaining to exceptions occurring during the donation process.
• Reviews electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Reviews donor deferral notifications from competitor centers.
• Reviews plasma processing documentation to ensure the proper freezing, storage and handling of product.
• Assist with training programs: creates, maintains, and audits training records and files.
• Performs employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• On occasion, review and approve deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.
• Reviews monthly trending report.
• Performs review of donor adverse events reports and related documentation.
• Conducts training to address donor center corrective and preventative measures.

Conoscenze

Interpersonal skills

Organizational skills

Problem-solving

FDA regulations

Quality compliance

Mathematics knowledge

Computer proficiency

SOP compliance

cGMP knowledge

Attention to detail

Formazione

High school diploma or GED

State licensures or certifications if applicable

Descrizione del lavoro

Grifols in Beaumont, TX is seeking a Quality Systems Associate to support quality assurance and training under the Quality Systems Manager, ensuring compliance with cGMP and regulatory protocols. You will review equipment QC, investigate deviations, release products, and maintain audit-ready documentation while supporting training programs and center operations.

The role emphasizes attention to detail, problem-solving, and adherence to SOPs, with opportunities to contribute to donor safety and