• Maintain compliance with all federal, state, and local regulations (e.g., FDA approved SOPs, OSHA, CLIA, GMP) to uphold production, safety, and quality standards.
• Assist with internal and external inspections conducted by regulatory agencies and customers.
• Collaborate on quality improvement initiatives, identifying process optimization opportunities and implementing best practices.
• Partner with departments to implement corrective and preventive actions (CAPA) and ensure timely resolution of identified issues.
• Promote Safety, Health, and Environmental policies; provide training, enforce practices, and mitigate unsafe conditions within the center.
• Oversee preventive maintenance of donor center equipment and ensure the facility remains clean, neat, and well-maintained.
• Safeguard the integrity of product and sample storage equipment; manage unsuitable product, prepare shipments, and mitigate equipment failures in compliance with SOPs.
• Support fiscal performance by assisting with production goals, operational cost control, and inventory management.
• Provide input on employee performance evaluations, development plans, and corrective actions, and collaborate on employment decisions (hiring, promotions, demotions, terminations).
• Foster a positive and inclusive culture aligned with core values, ensuring adherence to HR policies, benefits, ADA accommodations, and employee relations standards.
• Serve as a Designated Trainer by conducting job and certification training, assessing progress, and adapting methods to meet learning and regulatory needs.
• Maintain visible leadership through area walkthroughs, providing support to ensure productivity and address operational deficiencies.
• Cultivate strong donor relationships by fostering retention, referrals, and growth, resolving complaints, and supporting marketing and advertising initiatives.
• Manage scheduling, payroll records, and staff meetings to ensure efficient allocation of resources and organizational effectiveness.
• Performs other duties as assigned.