Quality Systems Associate

GRIFOLS, S.A. • Brookings, SD

6d • Onsite

About The Position

Under the direct supervision of the Quality Systems Manager, the Quality Systems Associate performs quality assurance and training functions to support compliance with internal and external regulations, protocols, cGMP requirements, SOPs, and regulatory requirements. The role reviews equipment, donor, product, shipment, and quality documentation; investigates deviations and complaints; supports product release; and helps maintain center training programs and employee competency. The associate is certified and maintains certification as a Donor Center Technician. The work is performed in a plasma center and includes documentation review, training observations, and exposure to biological fluids, laboratory and office equipment, and extreme cold in plasma freezers. The position may require physical activity such as prolonged sitting or standing, bending, twisting, frequent hand and foot movements, and light lifting.

Requirements

• High school diploma or GED.
• Typically requires no previous related experience.
• Obtains state licensures or certifications if applicable.
• Ability to understand FDA regulations and follow SOPs and protocols.
• Strong integrity and commitment to quality and compliance.
• Good knowledge of mathematics and legible handwriting.
• Proficiency with computers.
• Ability to work flexible schedules to meet business needs.
• Developing interpersonal communication, organizational, and problem-solving skills.
• Ability to perform basic document reviews and employee observations, and to communicate review issues to the CQM.
• Basic understanding of cGMP and quality systems, and ability to perform the primary responsibilities of the Quality Associate role proficiently.
• Attention to detail and good organizational skills.
• Ability to sit and review documentation for accuracy for hours at a time.
• Ability to communicate information clearly, listen to and understand spoken information, work independently with little guidance, handle variable tasks and changing conditions, and relate sensitive information to diverse groups.
• Ability to meet the stated occupational demands, including frequent hand and foot movements, occasional bending and twisting, and light lifting.

Responsibilities

• Completes weekly reviews of equipment quality-control and maintenance records.
• Documents and investigates deviations and customer complaints, performing root-cause analysis related to product quality and donor safety.
• Inspects and releases incoming supplies, and investigates and reports supplies that fail to meet quality specifications before use.
• Reviews documentation for unsuitable test results.
• Assists the Quality Systems Manager in ensuring cGMP regulations, SOPs, and regulatory requirements are followed.
• Performs product-release activities.
• Reviews lookback information and documentation.
• Reviews waste-shipment documentation.
• Reviews unexpected plasmapheresis events, including electronic donor charts and related documentation about donation-process exceptions.
• Reviews electronic donor-chart exceptions that may affect donor eligibility, safety, or product quality.
• Reviews donor-deferral notifications from competitor centers.
• Reviews plasma-processing documentation to ensure proper freezing, storage, and handling of product.
• Assists the Quality Systems Manager in ensuring center training programs meet procedural requirements in donor-center SOPs and training-program documents.
• Creates, maintains, and audits training records and files for compliance.
• Conducts employee training observations to verify competency before employees work independently.
• Conducts required training for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.
• When the Quality Systems Manager is absent, may review and approve deferred-donor reinstatement activities and assist with the internal donor-center audit.
• Reviews monthly trending reports.
• Reviews donor adverse-event reports and related documentation.
• Conducts training to address donor-center corrective and preventive measures.
• Maintains certification as a Donor Center Technician.
• Performs other duties as assigned by managers or supervisors.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED