Job Summary

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.

Essential Responsibilities

Operational Leadership- 35%

• 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.

Quality & Regulatory Compliance- 25%

• 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- 20%

• 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- 8%

• 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- 7%

• 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- 5%

• 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.

Education

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

Experience

• 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.

Preferred Qualifications

• 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.

About Gulf Coast Blood

Gulf Coast Blood is a non-profit 501 (c) (3) organization and is accredited, licensed and inspected by the Food and Drug Administration (FDA), AABB as well as local and state authorities. Serving the largest medical campus in the world, Gulf Coast Blood has grown to more than 750 employees and serves more than 170 hospitals and health care institutions in the 26-county Texas Gulf Coast, Brazos Valley and East Texas regions. As it pertains to stability, we have been in business over 50 years with no threat of mergers or acquisitions; and growing stronger as we gain more partnerships within the business community. Mission: To partner with the community to help save and sustain lives by providing a safe supply of blood, biotherapies and related services. Core Values: Commitment. Integrity. Respect.

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