Assistant Manager - Component Production

Essential Responsibilities

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

Quality & Regulatory Compliance

• 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.

People Leadership

• 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.

Training & Competency

• 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.

Continuous Improvement

• 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.

Safety & Risk Management

• 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.