Quality Systems & Training Specialist

Grifols; Fort Worth (TX); On-site; USD 58,000 - 78,000; Full time

Job summary

Grifols is seeking a Quality Systems Associate to support QA and training activities in a plasma center environment. You will ensure compliance with cGMP, SOPs and regulatory requirements while assisting the Quality Systems Manager in center training programs.

The role involves reviewing documentation, performing audits, and participating in ongoing quality improvement initiatives to ensure donor safety and product quality.

Qualifications

• 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.

Responsibilities

• Creates, maintains, and audits training records and files to ensure compliance.
• 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.
• Reviews and approves of deferred donor reinstatement activities.
• Assists with completion of the internal donor center audit.
• 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 the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.

Skills

Interpersonal communication

Organizational skills

Problem-solving

FDA regulations

Quality and compliance

Mathematics

Legible handwriting

Computers

Flexible scheduling

Document review

Employee observations

SOPs and protocols

cGMP knowledge

Attention to detail

Education

High school diploma or GED

State licensures or certifications

Job description

Grifols is seeking a Quality Systems Associate to support QA and training activities in a plasma center environment. You will ensure compliance with cGMP, SOPs and regulatory requirements while assisting the Quality Systems Manager in center training programs.

The role involves reviewing documentation, performing audits, and participating in ongoing quality improvement initiatives to ensure donor safety and product quality.