1-3 years of experience
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Employment Type:
Full time
Job Category:
Health Care Provider
Director of Lab Operations
(This job is no longer available)
Octapharma Plasma, Inc. | Charlotte, NC
Grad Date

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Job Description

  • P & L Responsibility for Laboratory Operations for all OPI plasma production volume for viral marker and hyperimmune testing.   Develops and implements appropriate laboratory strategies that support the overall company strategy by leading and directing all laboratory staff and processes.
  • Responsible for the ongoing operations of the viral marker and hyperimmune laboratory.
  • Initiates the hiring and training of all lab staff, prepares performance reviews, provides coaching and guidance to staff in achieving strategic objectives, goals and core values.
  • Allocates resources to assure that the laboratory meets the production requirements while maintaining a quality level that meets all regulatory requirements.
  • Assures all facets of people, equipment, documentation, supplies, and procedures are compliant to all required regulatory agencies.
  • Organizes and prioritizes workloads and assignments of staff in conjunction with the requirements of the donor centers and direction provided by the Senior Director of Supply Chain.
  • Ensures timely delivery of test results and products from the laboratory to OPI’s internal and external customers.
  • Reviews test results for accuracy, completeness, and compliance to requirements and release test data.
  • Oversees the hyperimmune program to ensure compliance to regulations and customer requirements.
  • Identifies and implements methods of enhancing the hyperimmune program as it relates to potency, effective utilization of cells and conversion rates.
  • Reviews documentation and records related to the preparation, storage, vialing, and distribution of immunogen cells. 
  • Maintains quality assurance programs including proficiency testing, laboratory accreditation, licensing and registration.
  • Supports the Company Quality Assurance system by ensuring:
  1. Corrective and preventive actions are developed and implemented in accordance with the Error Management system.
  2. Quality control activities are performed in accordance with defined maintenance and calibration schedules.
  3. Key Performance Indicator (KPI) targets are consistently met.
  • Acts as a host in audits/inspections of the laboratory by customers, internal auditors, and external regulatory bodies.
  • Provides technical support for internal issues, customer inquiries, and external laboratories as required.
  • Supports the development of programs to improve laboratory efficiency and reduce costs.
  • Provides information for reports to OPI senior management regarding laboratory activities.
  • Participates in the process to evaluate new test methods and equipment.  
  • Interacts with donor centers and other departments for problem resolution.  Identification of problems may be detected through complaint system, tracking and trending or audit process.
  • Initiates laboratory SOPs or modifications as required.

·         As a laboratory subject matter expert, serves as a participant of the Change Control Board as needed.

  • Performs other duties as assigned by the Senior Director of Supply Chain.
  • Bachelor's degree in a laboratory science, or medical laboratory technology from an accredited institution is required
  • Must have at least 2 years of laboratory training or experience, or both, in high complexity testing
  • Must qualify as a General Supervisor in accordance with federal regulations 493.1461 and 493.1462 - Licensure of Clinical Laboratories and CLIA
  • In depth knowledge of blood bank phenotyping.
  • Knowledge of laboratory testing with the ability to analyze, identify, and question procedures regarding sensitivity, specificity, precision, optimization, etc.
  • Excellent project management skills with the ability meet deadlines.
  • Excellent analytical skills, interpersonal, and organizational skills.
  • Minimum of 7 years related experience in a clinical laboratory required.
  • Minimum of 3 years supervisory/managerial experience, preferred.     
  • Ability to work independently.
  • Demonstrated organizational skills, including the ability to be flexible to changing priorities, and to handle multiple tasks.
  • Ability to schedule and plan workloads, implement systems and projects that align with strategic objectives of the company. 
  • Demonstrated experience working in a regulated environment and an understanding of regulatory compliance mandated, at minimum, by FDA, CLIA, and EU.
  • Willingness to work diverse shifts and overtime as required.

About Octapharma Plasma, Inc.

We believe the growth and success of each of our employees is an important part of the continued growth and success of our company. We create a workplace known for teamwork and recognition based on the following values: Customer Focus Leadership Integrity Team Spirit Self Respect Respect for Others Life Balance Safety