Assistant Manager - Component Production

Position Title:

Assistant Manager - Component Production

The Assistant Manager, Component Production is responsible for supporting the operational leadership of the Component Production department to ensure the safe, timely, and compliant manufacture of blood components. This position partners closely with the Component Production Manager to oversee daily operations, lead staff, maintain regulatory compliance, drive operational excellence, and promote a culture of quality, safety, and continuous improvement.

The Assistant Manager serves as the acting department leader in the absence of the Manager and provides leadership in workforce management, quality systems, process improvement, regulatory readiness, and employee development.

• Support the day-to-day management of Component Production operations to ensure production goals, quality standards, and customer service expectations are achieved.

• Assume full operational responsibility for the department in the absence of the Component Production Manager.

• Monitor workflow, staffing levels, productivity, and turnaround times to optimize operational performance.

• Coordinate daily operational priorities and allocate resources effectively to meet business demands.

• Collaborate with cross-functional departments to ensure efficient production and service delivery.

• Ensure compliance with all applicable FDA, AABB, CLIA, OSHA, cGMP, CAP, and organizational standards.

• Monitor adherence to Standard Operating Procedures (SOPs) and quality system requirements.

• Lead investigations related to deviations, non-conformances, corrective and preventive actions (CAPA), and error management.

• Support internal audits, external inspections, and accreditation assessments.

• Maintain inspection readiness through continuous monitoring and process improvement.

• Supervise, coach, and develop laboratory staff to achieve departmental objectives.

• Foster a culture of accountability, collaboration, engagement, and continuous learning.

• Monitor employee performance through regular coaching, feedback, and performance evaluations.

• Support recruitment, onboarding, orientation, competency assessments, scheduling, and workforce planning.

• Address employee relations matters in partnership with People & Culture.

• Promote employee retention through career development and engagement initiatives.

• Oversee new employee onboarding, training, and competency assessment programs.

• Ensure all employees maintain required certifications and annual competencies.

• Identify knowledge gaps and implement training initiatives that improve operational effectiveness.

• Identify opportunities to improve quality, efficiency, productivity, and cost effectiveness.

• Utilize Lean, Six Sigma, or continuous improvement methodologies where appropriate.

• Participate in process redesign and workflow optimization initiatives.

• Monitor operational metrics and implement corrective actions to improve performance.

• Promote a safe laboratory environment by ensuring compliance with all safety policies and procedures.

• Support emergency preparedness activities.

• Ensure appropriate corrective action is taken for safety incidents and near misses.

• Promote a culture of quality, accountability, and continuous improvement.

• Bachelor’s degree from an accredited college or university in Medical Technology, Clinical Laboratory Science, Biology, Chemistry, Life Sciences or related scientific discipline

• Minimum five (5) years of progressive laboratory or blood component manufacturing experience.

• Minimum four (4) years of supervisory or leadership experience.

• Experience working within FDA-regulated or highly regulated healthcare environments.

• Experience managing quality systems and regulatory inspections preferred.

• Demonstrated advanced knowledge of blood component processing and manufacturing operations.

• Excellent attention to detail and organizational skills.

• Strong communication, problem-solving, and critical-thinking abilities.

• Ability to manage multiple priorities and make sound decisions in a fast-paced environment.

• Current HIPAA certification.

• Familiarity with continuous improvement methodologies (e.g., Lean, Six Sigma) or structured laboratory improvement programs.

• Knowledge of FDA regulations, AABB Standards, FACT Standards, cGMP, CAPA, RC and quality management systems.

• Experience working in a cleanroom or controlled manufacturing environment.

Key Competencies

• Blood Component manufacturing

• Leadership and Influence

• Training and Mentorship

• Operational Coordination

• Quality and Regulatory Compliance

• Problem Solving and Decision Making

• Process Improvement

• Communication and Collaboration

• Accountability

• Customer Focus

Supervisory Responsibility

• Assists the Manager in executing supervisory responsibilities in accordance with organizational policies and…