Center Manager

5 days ago

Ogden, Utah, United States KEDPLASMA LLC. Full time
Job Description

KEDPLASMA LLC. offers a dynamic and rewarding work environment with opportunities for professional growth and development. We are seeking a highly skilled and experienced Center Manager to join our team.

Key Responsibilities:
  • Regulatory Compliance: Ensure that all Center activities are in compliance with Kedplasma DCOP's (Donor Center Operating Procedures) and other Company standards and protocols to meet the regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies.
  • Operational Management: Includes training in all operational areas, ensures proper equipment maintenance, calibration, and cleaning schedules as required, and maintains freezer and refrigerators within required temperature ranges and maintenance requirements.
  • Facility Management: Ensures the facility is well-maintained, safe, clean, and neat at all times, and maintains a thorough understanding of State and Federal regulations (e.g., FDA approved Standard Operating Procedures, OSHA, CLIA, IQPP Standards, and cGMPs) to maintain the highest production standards and ensure facility compliance.
  • Quality Assurance: Reviews test results to ensure that abnormal and reactive test results include prompt unit culling and quarantine, computer entry, execution of lookbacks, and final disposition of product, and holds regular meetings with QAM for revisions and updates to training.
  • Problem Resolution: Maintains all aspects of daily center functions (e.g., personnel, products, donors, computers, etc.), keeps immediate supervisor informed of any irregularities within the center, and provides constructive information about process improvements.
  • Inventory and Sample Management: Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules, and ensures that center is in compliance with directives on shipping listed in the DCOP and instructions provided by the corporate logistics group.
  • Staff Supervision, Training, and Development: Trains, develops, and manages all staff in accordance with the Employee Handbook and Policy Manual, DCOP's, Training Manual, and other established management guidelines and regulations, and ensures adequate, trained staff is available to cover the hours of operation in adherence to regulatory requirements.
  • Budget and Fiscal Control: Maintains a professional and courteous relationship with donors that will stimulate donor retention, referrals, and production growth, and ensures projected production budget is met in quantity, quality, and within required titer requirements.

Requirements:

  • Bachelor's degree in science or management-related field required.
  • Previous work experience demonstrating decision-making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service.
  • Excellent communication skills and ability to conduct oral presentations.
  • Excellent people skills that extend to a diverse group of individuals and demographics.
  • Three to five years of working experience in a biomedical field preferred or a combination of advanced education and related experience.
  • Ability to speak, read, and write in English.
  • Professional appearance and demeanor.
  • Ability to operate computer software, including DMS (with training) and Microsoft Office.

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