Quality Systems Associate

Quality Systems Associate

Summary:

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.

• Completes weekly review of equipment QC and maintenance records.
• Documents, investigates, and performs root‑cause analysis for deviations and customer complaints, specifically in how they related to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies that have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Performs all product release activities.
• Reviews look‑back 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.
• 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 deferred donor reinstatement activities (when Quality Systems Manager is absent).
• Assists with completion of the internal donor center audit (when Quality Systems Manager is absent).
• Performs review of monthly trending report.
• Performs review of donor adverse events reports and the applicable related documentation.
• Conducts training to address donor center corrective and preventative measures.

• 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 and 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.
• Basic understanding of cGMP and quality systems.
• Spends hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

High school diploma or GED. Obtains 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 degrees 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 to 6 hours per day and standing from 2 to 4 hours per day.

The position does require bending and twisting of neck