Clinical Laboratory Operations Manager - Job # 2300

Additional Information
  • For confidential consideration please submit a resume and salary history to claire@fullscalesolutions.com.
  • Please be sure to include the job number with your submission.
  • Full Scale Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.
Client Synopsis:

Full Scale Solutions is currently recruiting for the following position that could be based in RTP, NC.

Essential Duties and Responsibilities:

The Clinical Laboratory Operations Manager will create, implement and manage the policies, procedures and practices for optimal performance of the Clinical Laboratory performing molecular diagnostics. This position will develop strategies for proper laboratory oversight; provide direct administration of all clinical laboratory procedures and operations in accordance with industry standards, contractual agreements, and regulatory requirements. The ideal candidate will have strong employee development skills and experience working in a high throughout laboratory environment. The schedule will be: Tuesday-Saturday, 10:00am-6:30pm.

Responsibilities will include, but are not limited to:

  • Implement laboratory procedures, including quality control and validation and implementation of new assays, instrumentation and methods.
  • Support Business Development and strategic planning for new analytical technologies.
  • Prepare, review, and approve procedures.
  • Maintain appropriate laboratory accreditation and quality assurance programs.
  • Serve as laboratory departmental liaison during government inspections and audits.
  • Assist preparing, developing and critiquing proposals to ensure complete, high quality proposal submission.
  • Ensure processes and services are monitored for quality, cost effectiveness, and efficiency through continuous process and quality improvement.
  • Recommend and implement ideas to improve operational efficiency.
  • Ensure services are provided in accordance with state and federal regulations, lab policy, and accreditation and compliance requirements.
  • Monitor quality metrics and access the quality systems of the lab.
  • Establish and maintain effective working relationships.
  • Provide information to senior management on the implication of policies and procedures, and recommend specific actions.
  • Responsible for staff hiring, training and development.
  • Demonstrate understanding of safety issues specific to a CLIA environment.
  • Manages staff including recruiting, hiring, motivating, performance management, training and development.

Requirements:

  • B.S. in Medical Technology, Biology , Chemistry or related areas, Master’s degree in Science preferred.
  • Specialty certification through ASCP (MB) in molecular biology, Certified Medical Technologist, or equivalent desired.
  • Minimum of 8 years clinical laboratory experience required. Minimum of 2 years as a manager or supervisory role required.
  • Previous experience working in a molecular biology laboratory highly preferred. Experience with Sequencing and within a high throughput environment desired.
  • Thorough knowledge of compliance requirements is required (i.e. CLIA, CAP, CA, NY state).
  • Experience with inspections/audits by CLIA, CAP, CA, NY state and other regulatory agencies.
  • Working knowledge of laboratory instruments (e.g. HPLC, GC, Mass Spec, PCR, etc.), computers and test methods used in a laboratory setting.
  • Demonstrated leadership skills, and ability to create, implement and monitor quality metrics.
  • Strong employee development skills.

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