Quality Specialist

Role: Quality coordinator supporting plasma center compliance and regulatory adherence, reporting to the Assistant Manager of Quality. Responsibilities: perform final QA review and release for shipments, maintain accurate records, oversee training programs, conduct process assessments, lead internal audits, and ensure adherence to SOPs, GxP, and applicable regulations (FDA, CLIA, COLA). Collaborate with management during audits, coordinate retraining initiatives, and promote safety and quality improvements. Qualifications: high school diploma required; associate or bachelor’s in business or biological sciences preferred. Minimum 1-year leadership or regulated environment experience; strong organizational, decision-making, and problem-solving skills; understanding of quality systems and regulatory training. High-value specifics: plasma collection setting, regulated environment, cGMP, FDA, CLIA/COLA compliance, internal/external audits, training management, quality system oversight, patient safety, and process improvement. Work setup: primarily on-site with physical requirements including standing, walking, and lifting up to 25 lbs.; occasional exposure to temperature variations, odors, and working with medical supplies.