Quality Systems Associate

GRIFOLS, S.A.•WA-Everett, CA

1d•$24 - $33•Onsite

About The Position

The Quality Systems Associate performs quality assurance and training functions under the direct supervision of the Quality Systems Manager to ensure compliance with internal and external regulations, protocols, cGMP requirements, SOPs, and regulatory requirements. The position is based in a plasma center and includes reviewing quality, donor, product, and training documentation, as well as supporting employee competency and compliance. The associate is certified and maintains certification as a Donor Center Technician. The role involves work in an environment with potential exposure to biological fluids and infectious organisms, electrical office and laboratory equipment, and temperatures below 32°F in plasma freezers. Required protective equipment includes protective eyewear, garments, gloves, and cold-weather gear. Work includes extended periods of sitting and standing, frequent hand and foot movements, occasional walking, bending and twisting, and light lifting up to 15 pounds, with a maximum lift of 50 pounds.

Requirements

High school diploma or GED.
Obtain state licensures or certifications if applicable.
Typically, no previous related experience is required.
Ability to understand FDA regulations and follow SOPs and protocols.
Basic understanding of cGMP and quality systems.
Ability to perform the primary responsibilities of a Quality Associate proficiently.
Developing interpersonal communication, organizational, and problem-solving skills.
Strong integrity and commitment to quality and compliance.
Good knowledge of mathematics and legible handwriting.
Proficiency with computers.
Ability to work a flexible schedule to meet business needs.
Ability to perform basic document reviews and employee observations.
Ability to communicate issues identified during reviews openly with the CQM.
Ability to sit and review documentation for accuracy for hours at a time.
Attention to detail and good organizational skills.
Ability to work independently with little guidance or reliance on oral or written instructions, adapt to variable demands and changing conditions, and communicate sensitive information to diverse groups.
Hearing acuity; color perception and discrimination; and near and far vision correctable to 20/30 in one eye and 20/100 in the other eye.
Ability to communicate information and ideas clearly and to listen to and understand spoken information.
Ability to meet the described physical demands, including frequent hand and foot movements, occasional bending and twisting, and lifting.

Responsibilities

Review equipment quality-control and maintenance records weekly.
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 or requirements 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 documentation related to exceptions during donation.
Review electronic donor-chart exceptions that may affect donor eligibility, safety, or product quality.
Review donor-deferral notifications from competitor centers.
Review plasma-processing documentation to verify proper freezing, storage, and handling of product.
Assist the Quality Systems Manager in ensuring center training programs comply with donor-center SOPs and training-program documents.
Create, maintain, and audit training records and files for compliance.
Observe employee training to confirm staff competency before employees are released to work independently.
Conduct required training 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 the internal donor-center audit.
Review monthly trending reports.
Review donor adverse-event reports and applicable related documentation.
Conduct training to address donor-center corrective and preventive measures.
Maintain certification as a Donor Center Technician.
Perform other duties as assigned by managers or supervisors.