Quality Specialist

Role: Quality Assurance Coordinator supporting plasma center operations, ensuring compliance with SOPs, regulations, and quality standards. Responsibilities: perform final QA review and release for shipments, maintain accurate records, manage training documentation and LMS data, coordinate and monitor staff training, conduct process assessments, identify non-conformities, lead internal/external audits, investigate and close Trackwise reports, maintain a safe work environment, and support regulatory compliance across cGMP, OSHA, FDA, and other agencies. Requirements: High school diploma; 1+ year leadership or regulated environment experience; strong organizational, decision-making, problem-solving, and customer service skills; understanding of Quality Systems and training requirements. Preferred: Associate or Bachelor’s degree in business or biological sciences. High-value biopharma specifics: regulated environment, cGMP, FDA, OSHA compliance, training management, audit hosting, and document control. Work Setup: primarily on-site with physical requirements such as standing, walking, occasional lifting; exposure to temperature variations; no travel specified.