1+ months
2018-07-242018-10-18

Manager, CAP CLIA Laboratory Operations

Roche
Tucson, AZ

Responsible for the day-to-day supervision and oversight of the high-complexity testing laboratory operation and personnel. The duties involve training and assessing the competencies of personnel, validating new assays, instruments and technology and creating and revising operating procedures. Works closely with the CAP/CLIA laboratory medical director, CDx Biosample Management (BSM), in-house pathologists, clinical sciences management (CSM), Assay Development team, Companion Diagnostics team, and other divisions of Ventana/Roche.in ensuring quality control and quality assurance and compliance with CAP, CLIA, state and federal regulations; Assists in creating department budget, managing finances, and interacting with clients.

ESSENTIAL FUNCTIONS:

  • Manages laboratory specializing in clinical trial patient testing including but not limited to IHC and ISH tissue staining, on a day-to-day basis ensuring provision of high quality patient results to pharma clients.
  • Ensures all assays are validated prior to implementation. Monitors quality control and quality assurance of testing.
  • Shares oversight with Senior Supervisor of CDx Biosample Management on the criteria for accessioning, sample handling, and inventory management.
  • Supervises employee performance through annual review process, ongoing feedback, and corrective action when necessary. Ensures that all staff has ongoing opportunities for continuing education and that all certifications/qualifications remain valid. Performs competency assessment for laboratory staff.
  • Participates in proficiency testing for ensuring quality of patient testing.
  • Troubleshoots issues associated with staining, instruments, or reagent performance. Ensures laboratory equipment and facilities are maintained per quality systems.
  • Participates in the safety committee in ensuring compliance with CAP, CLIA, and Roche regulations.
  • Represents the laboratory during internal and external client audits, CAP, CLIA and FDA inspections.
  • Assists CAP laboratory medical director in:
    • Overseeing laboratory for capacity, workflow and throughput to meet current and future needs of clients.
    • Presenting laboratory needs to senior management in regards to budgeting, staffing or issue impacting productivity or quality.
    •  Responding to client questions.
  • Attends scientific symposia to keep aware of new technologies, and compliance requirements for the laboratory.
  • Assists other Ventana/Roche projects as needed.

MINIMUM QUALIFICATIONS:

Formal Training/Education:

  • Bachelor's degree in a chemical, physical, biological or clinical laboratory science or medical technology with at least one year experience with high complexity testing, OR
  • Associate degree in a laboratory science or medical technology program with at least two years of experience with high complexity testing.
  • Current Certification by ASCPâs Board of Certification as a Histotechnician (HT) or Histotechnologist (HTL) required.
  • Current Qualification by ASCPâs Board of Certification in Immunohistochemistry is preferable.

Experience:

  • 5 years of working experience in histology labs with at least 2 years of experience as a lab manager or supervisor.
  • Experience in a clinical anatomic pathology laboratory is preferable. Experience with new technologies such as digital pathology and molecular pathology is desirable.

Knowledge, Skills, and Abilities:

  • CAP and CLIA requirements specific for Anatomic Pathology
  • Experience in routine clinical histological techniques, validation and troubleshooting
  • Ability to work with multiple stake holders and cross functional teams.
  • Skilled in managing teams.
  •  Excellent verbal and written communication skills.

Roche is an equal opportunity employer.

Research & Development, Research & Development > Clinical Development

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Manager, CAP CLIA Laboratory Operations

Roche
Tucson, AZ

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