Quality Systems Associate

Grifols•Alexandria, LA

6d•Onsite

About The Position

The Quality Systems Associate performs quality assurance and training functions under the direct supervision of the Quality Systems Manager to help ensure compliance with internal and external regulations, protocols, cGMP requirements, and SOPs. The role is based in a plasma center and includes reviewing quality, product, donor, and training records; investigating deviations and complaints; and supporting the center’s training and quality systems. The associate is certified and maintains certification as a Donor Center Technician. The position involves extensive documentation review, as well as time spent sitting and standing in the plasma center. Work may include exposure to biological fluids and infectious organisms, electrical office and laboratory equipment, and temperatures below 32°F in plasma freezers. Required personal protective equipment may include protective eyewear, garments, gloves, and cold-weather gear.

Requirements

High school diploma or GED.
Typically no previous related experience is required.
Obtain applicable state licensures or certifications.
Ability to understand FDA regulations and follow 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 carry out the primary responsibilities of a Quality Associate proficiently.
Attention to detail and good organizational skills.
Ability to work flexible schedules to meet business needs.
Ability to sit and review documentation for accuracy for several hours.
Ability to communicate information clearly, listen and understand spoken information, work independently with little guidance, handle variable demands, and relate sensitive information to diverse groups.
Ability to meet the listed physical and sensory demands, including frequent hand and foot movement, occasional bending and walking, light lifting, and required hearing and vision capabilities.

Responsibilities

Review equipment quality-control and maintenance records weekly.
Document and investigate deviations and customer complaints, including performing root-cause analysis related to product quality or donor safety.
Inspect and release incoming supplies, and 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, waste shipment documentation, unexpected plasmapheresis events, electronic donor chart exceptions, and donor deferral notifications from competitor centers.
Review plasma processing documentation to verify proper freezing, storage, and handling.
Create, maintain, and audit training records and files for compliance.
Observe employee training to verify staff competency before employees are released to work independently.
Conduct 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 internal donor center audits.
Review monthly trending reports and donor adverse-event reports and related documentation.
Conduct training to address donor-center corrective and preventive measures.
Maintain certification as a Donor Center Technician.
Communicate issues identified during reviews to the CQM.