Specialist, Quality Assurance

Role Summary

Specialist, Quality Assurance. Responsible for ensuring center activities comply with SOPs and regulatory readiness; assists in development of policies, procedures, and processes to reduce errors; monitors quality initiatives and conducts investigations with root cause analysis and corrective/preventive actions.

Responsibilities

• Assures the Plasma Center(s) are in compliance with applicable guidelines.
• Reports deviations (cGMP) or regulatory practices to the Quality Director.
• Ensures SOPs, policies, and practices are updated and staff perform in accordance with SOPs through audits and observations.
• Authorizes release of final product and can stop shipment for non-conforming product.
• Ensures accurate labeling and documentation of shipments.
• Maintains readiness for regulatory and customer audits.
• Tracks and trending of errors, corrective actions, and approval of preventive actions.
• Reports compliance status to necessary parties.
• Ensures accuracy of electronic donor records in the donor center system.
• Ensures supplies and materials meet quality regulations prior to use.
• Monitors maintenance and calibration of equipment and documents as required.
• Ensures training completion for new employees and annual competency training for existing staff.
• Oversees execution, documentation, and review of internal and external audits.

Qualifications

• Education: Bachelor’s degree or equivalent professional experience.
• Experience: at least one year of Quality Assurance experience in a Donor Center or similar QA/medical field.
• Competencies: follow cGMPs with attention to detail; work under pressure to meet deadlines; basic computer skills (Word, Excel, GroupWise); ability to achieve goals and work with diverse teams; strong organizational and communication skills.

Skills

• Quality Assurance
• cGMP compliance
• Auditing and corrective/preventive actions
• Documentation and record-keeping
• Data analysis and trend monitoring
• Training and staff development

Education

• Bachelor’s degree or equivalent professional experience

Additional Requirements

• None beyond role-described qualifications; travel/physical demands not specified as essential.