Plasma Center Operations Lead

Kedrion

Irving (TX)

Presencial

USD 58.000 - 74.000

Jornada completa

Hace 3 días
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Ventajas ofrecidas por este puesto de trabajo

Health & Wellness
Financial Security
Work-Life Balance
Career Growth
Extra Perks

Descripción de la vacante

Kedrion Biopharma Inc. is seeking an Assistant Manager to lead our plasma collection center operations in Irving, TX. You will support the Center Manager, ensure regulatory compliance, coach staff, and drive donor satisfaction while maintaining safety, quality, and cost controls.

You will oversee staffing, scheduling, equipment oversight, and daily logs, ensuring adherence to SOPs and cGMP standards and maintaining high-quality donor programs in a fast-paced, regulated environment.

Formación

  • Bachelor's degree in healthcare, life sciences, business, or related field.
  • Minimum 1 year supervisory or management experience in plasma or regulated setting.
  • Knowledge of FDA, CLIA, and cGMP regulations preferred.
  • Strong organizational and leadership skills.
  • Proficiency in Microsoft Office and data entry systems.
  • Willingness to work in regulated environments with exposure to bloodborne pathogens and cold storage.

Responsabilidades

  • Promote professional customer service and donor retention through staff coaching and support.
  • Ensure all center activities comply with SOPs, FDA, EMEA, and customer specifications.
  • Maintain operational efficiency and fiscal responsibility in accordance with cGMP and QAP standards.
  • Support special donor programs, including titer testing and antibody identification.
  • Oversee completion of daily logs and records, including temperature checks and quality control.
  • Collaborate with management to ensure appropriate staffing and coverage for donation volumes.
  • Maintain accurate personnel records, including evaluations, training, and attendance.
  • Assist in scheduling and preparing for staff changes, vacations, and absenteeism.
  • Identify and address quality or compliance issues proactively.
  • Monitor inventory levels and ensure adequate stock for production needs.
  • Manage equipment maintenance schedules and resolve equipment issues promptly.
  • Respond to freezer alarms and resolve excursions to protect product quality.
  • Participate in deviation management, including documentation, investigations, and CAPA implementation.
  • Perform opening and closing duties, including equipment checks, documentation, security protocols, etc.

Conocimientos

Leadership
Regulatory compliance
Donor operations
Staff coaching
Quality control
SOP adherence
Data entry proficiency
Microsoft Office

Educación

Bachelor’s degree in healthcare or life sciences

Herramientas

Microsoft Office
Data entry systems
LIMS

Descripción del empleo

Kedrion Biopharma Inc. is seeking an Assistant Manager to lead our plasma collection center operations in Irving, TX. You will support the Center Manager, ensure regulatory compliance, coach staff, and drive donor satisfaction while maintaining safety, quality, and cost controls.

You will oversee staffing, scheduling, equipment oversight, and daily logs, ensuring adherence to SOPs and cGMP standards and maintaining high-quality donor programs in a fast-paced, regulated environment.

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