Quality Systems Associate

Quality Systems Associate

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.

• Complete weekly review of equipment QC and maintenance records.
• Document, investigate, and perform root‑cause analysis for deviations and customer complaints related to product quality and/or donor safety.
• Inspect and release incoming supplies; investigate and report supplies that do not meet quality specifications and requirements prior to use.
• Perform documentation review for unsuitable test results.
• Assist the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Perform all product release activities.
• Review lookback information and documentation.
• Review waste shipment documentation.
• Review unexpected plasmapheresis events, including electronic donor chart and related documentation of exceptions occurring during the donation process.
• Review electronic donor chart exceptions impacting donor eligibility/safety and/or product quality.
• Review donor deferral notifications from competitor centers.
• Review 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.
• Create, maintain, and audit training records and files to ensure compliance.
• Perform employee training observations to ensure staff competency prior to releasing employees to work independently.
• Conduct required training activities 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 completion of the internal donor center audit.
• Perform review of monthly trending report.
• Perform review of donor adverse events reports and applicable related documentation.
• Conduct training to address donor center corrective and preventative measures.

Is certified and maintains certification as a Donor Center Technician.

• 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.
• Perform basic document review and employee observations.
• Communicate openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Perform primary responsibilities of the Quality Associate role proficiently.
• Basic understanding of cGMP and quality systems.
• Spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

High school diploma or GED. Obtain state licensures or certifications if applicable.

Typically requires no previous related experience.

Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 °F while performing reviews in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold‑gear. Work is performed mostly while sitting for up to 4–6 hours per day and standing from 2–4 hours per day.

The position does require bending and twisting of neck up from 2–4 hours per day. Frequent hand movement of both hands with the ability to make fast, simple movements of the fingers, hands, and wrists. Ability to make precise coordinated movements of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion.

Occasionally walks, bends and twists ht lifting of 15 lbs. with a maximum lift of 50 lbs. May reach below shoulder height. Hearing acuity…