• Maintain compliance with all federal, state, and local regulations (e.g., FDA approved SOPs, OSHA, CLIA, GMP) to ensure the highest production, safety, and quality standards.
• Assist with internal and external inspections, audits, and collaborate with departments to implement corrective and preventive actions (CAPA).
• Participate in quality improvement initiatives to enhance efficiency, optimize processes, and contribute to best practices.
• Promote and enforce Safety, Health, and Environmental policies; conduct safety training, mitigate unsafe conditions, and ensure a safe work environment.
• Oversee preventive maintenance of donor center equipment, ensuring operational readiness and facility cleanliness.
• Safeguard the integrity of product and sample storage equipment; prepare product shipments, manage unsuitable products, and mitigate equipment failures per SOPs.
• Support operational and fiscal goals by assisting with production targets, cost optimization, and inventory management.
• Provide input on employee performance management, including evaluations, improvement plans, and corrective actions, and support employment decisions such as hiring, promotions, and terminations.
• Foster a positive, inclusive culture within the center while ensuring adherence to HR policies, procedures, and employee relations practices.
• Act as a Designated Trainer, conducting on-the-job and certification training, assessing progress, and adapting teaching methods to regulatory and learner needs.
• Maintain visible leadership through area walkthroughs, provide assistance to ensure productivity and operational effectiveness.
• Cultivate positive donor relationships to encourage retention, referrals, and growth, while resolving complaints and supporting marketing initiatives.
• Manage scheduling, payroll records, and staff meetings to ensure efficient allocation of resources and productivity.
• Monitor and drive operational performance to Key Performance Indicators (KPIs), proactively addressing deficiencies and collaborating with leadership as needed.
• Perform other related duties as assigned.