Quality Systems Associate

Primary Responsibilities

• 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 relate 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 lookback 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.

Training Duties

• Assists the Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents.
• 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.

Additional Duties

• Reviews and approves deferred donor reinstatement activities when the Quality Systems Manager is absent.
• Assists with completion of the internal donor center audit.
• 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.

Knowledge, Skills, and Abilities

• 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.
• Performs basic document review and employee observations.
• Communicates openly with the CQM on issues noted during reviews.
• Ability to understand and follow SOPs and protocols.
• Has a basic understanding of cGMP and quality systems.
• Demonstrates good organizational skills and attention to detail.