Quality Systems Associate

About the role

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.

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 related to product quality and/or donor safety.
• Inspects and releases incoming supplies. Investigates and reports supplies have not met quality specifications and requirements prior to use.
• Performs documentation review for unsuitable test results.
• Affords assistance to the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed.
• Assists with the creation, maintenance, and auditing of 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 monthly trending report.
• Reviews donor adverse events reports and the applicable related documentation.
• Conducts training to address donor center corrective and preventative measures.

Qualifications

• Is certified and maintains certification as a Donor Center Technician.
• Develops 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 SOP’s and protocols.
• Ability to perform primary responsibilities of the Quality Associate role in a proficient manner.
• Has a basic understanding of cGMP and quality systems.
• Is able to spend hours sitting and reviewing documentation for accuracy.
• Demonstrates good organizational skills and attention to detail.

Education

• High school diploma or GED.

Additional Responsibilities

• Obtains state licensures or certifications if applicable.