Quality Systems Associate

GRIFOLS, S.A.•Pueblo, CO

7d•$19 - $26•Onsite

About The Position

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to help ensure compliance with internal and external regulations, protocols, cGMP requirements, and SOPs. The role reviews quality, donor, product, and training documentation and supports center training programs. The position is based in a plasma center in Pueblo, Colorado. The associate also maintains certification as a Donor Center Technician. When the Quality Systems Manager is absent, the associate may occasionally review and approve deferred donor reinstatements and assist with the internal donor center audit. Other duties may be assigned as needed.

Requirements

High school diploma or GED.
Obtain applicable state licensure or certifications.
Typically requires no previous related experience.
Understand FDA regulations, SOPs, and protocols.
Basic understanding of cGMP and quality systems.
Developing interpersonal communication, organizational, and problem-solving skills.
Strong integrity and commitment to quality and compliance.
Good knowledge of mathematics and legible handwriting.
Computer proficiency.
Ability to perform basic document reviews and employee observations and to perform primary responsibilities of the Quality Associate role proficiently.
Ability to work a flexible schedule to meet business needs.
Ability to sit for extended periods while reviewing documentation for accuracy.
Good organizational skills and attention to detail.
Ability to work independently with little guidance and handle variable demands and changing conditions.
Ability to communicate and understand spoken information and communicate sensitive information to diverse groups.
Physical ability to sit, stand, bend, twist, reach, and frequently use hands and fingers; occasional walking and waist bending or twisting; rare squatting, crouching, or sitting on heels; light lifting up to 15 pounds and maximum lifting up to 50 pounds.
Hearing acuity and specified corrected near and far vision and color perception/discrimination.

Responsibilities

Complete weekly reviews of equipment QC and maintenance records.
Document and investigate deviations and customer complaints, including root-cause analysis related to product quality or donor safety.
Inspect and release incoming supplies; investigate and report supplies that fail to meet quality specifications before use.
Review documentation for unsuitable test results.
Assist the Quality Systems Manager in ensuring compliance with cGMP regulations, SOPs, and regulatory requirements.
Perform product release activities.
Review lookback information and documentation.
Review waste shipment documentation.
Review unexpected plasmapheresis events, including electronic donor charts and related documentation for exceptions during donation.
Review electronic donor chart exceptions that may affect donor eligibility, donor 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 in ensuring center training programs follow procedural requirements in donor center SOPs and training documents.
Create, maintain, and audit training records and files for compliance.
Observe employee training to assess staff competency before employees work independently.
Conduct training for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
When the Quality Systems Manager is absent, occasionally review and approve deferred donor reinstatement activities and assist with the internal donor center audit.
Review monthly trending reports.
Review donor adverse event reports and related documentation.
Conduct training addressing donor center corrective and preventive measures.
Maintain certification as a Donor Center Technician.
Communicate issues identified during reviews to the CQM.