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Clinical Laboratory Manager

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    Location(s)
  • Pittsburgh, PA

Status Regular Job ID JR-010046 Recruiting Region Americas

Seeking a full-time Clinical Laboratory Manager. This is an exciting opportunity for an independent, creative, service-oriented individual to help build clinical sequencing laboratory services. The candidate will be responsible for daily supervision of a high throughput clinical genome sequencing center including oversight of laboratory technologists, technical trouble-shooting validation and testing processes, reviewing lab results, developing and writing operational procedures, monitoring laboratory key performance indicators, quality metrics and the QC program, timely reporting of quality event reporting to the laboratory director and to quality management, and provide regulatory, due diligence and internal auditing support. Must have experience working in a CLIA, CAP and NY State diagnostic laboratory and be able to apply regulation to clinical diagnostic operations.

Responsibilities:

  • Manage the daily operations of assigned laboratory personnel to ensure that specimens are properly shipped and received, tests are performed accurately and efficiently, and results are reported in a timely manner.
  • Perform pre-analytical, analytical and post analytical test process and evaluate results produced relative to the diagnostic assessment.
  • Evaluate data for accuracy and verify any questionable finding with proper documentation, thorough investigation, and appropriate follow-through.
  • Assist with designing processes and procedures to ensure efficient turn-around time and accuracy of results.
  • Prepare and manage laboratory budget.
  • Coach and mentor staff on technical expertise and assist in evaluation of employee competencies.
  • Engage in continuous process and service improvement. Make and implement recommendations to improve operational efficiency and implement new services for areas of responsibility.
  • Requires strict adherence to quality control guidelines to ensure integrity of laboratory specimens and accuracy of results.
  • Ensure all work is in accordance with state and Federal regulations, organizational policy, and accreditation/compliance requirements.
  • Assist in maintaining CAP and other accreditation and regulatory agency standards and regulations.
  • Performing bench work and other duties as required including shift work.

Minimum Experience:

  • Minimum of 10+ years of clinical experience with various techniques especially high throughput DNA Sequencing (NGS, Sanger) in a commercial, academic, or government laboratory.
  • Experience with nucleic acid–based assay development, process development, project management, vendor management and collaborative research.
  • Quality Assurance and Quality Control applications in clinical diagnostics.
  • Must be detail oriented, highly organized, with excellent verbal and written communication skills.
  • Ability to troubleshoot technical applications and work independently under pressure of deadlines and a fast paced, high throughput team environment.
  • Practical knowledge of routine laboratory equipment and procedures.
  • Experience with LIMS and laboratory automation highly desired.
  • Practical experience with clinical laboratory practices and protocols is a definite plus.
  • Certification as a MB (ASCP) by ASCP accrediting agency is required or to get certification within 6 months of employment.

Knowledge, Skills, & Abilities:

Language: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence.

Math Ability: Ability to work with mathematical concepts such as probability and statistical inference.  Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

Reasoning Ability: Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.  Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

Computer Skills: To perform this job successfully, an individual should have knowledge of Microsoft Word, Outlook, and Microsoft Excel.  Ability to operate laboratory computer systems.

Special Skills: Demonstrate effective interpersonal communications between departments and co-workers.

Communicate effectively (orally and written) with coworkers, employees of other departments, supervisors, and administration. Knowledge of quality control practices and regulations of CLIA, CAP, NY State and other regulatory agencies.

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PerkinElmer is committed to creating a diverse environment and is proud to be 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 status, age, or veteran status or any other characteristics protected by applicable law. PerkinElmer is committed to a culturally diverse workforce.

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