Laboratory Analyst (Medical Technologist)

• ROLE SUMMARY

  As a Laboratory Analyst (Medical Technologist) the individual is responsible for performing routine and special clinical laboratory testing using automated semi-automated and/or manual methods and equipment coordinating and organizing assigned laboratory sections (including Hematology Chemistry Urinalysis Immunoassay Coagulation and Biomarkers). Assumes analytical responsibilities for clinical pathology assays required on clinical trials. Responsibilities will also include quality control assist in the validation of new assays/instrumentation new employee training/mentoring documentation of data collection and other experiments serve as a back-up to instrument key operators perform instrument calibrations maintenance reagent inventory and sample processing. May serve as a back-up for pharmacokinetic biospecimen processing and sample shipping as required.

  ROLE RESPONSIBILITIES

  • Performs routine and special clinical chemistry hematological coagulation urinalysis immunological and other tests according to the Standard Operating Procedures.
  • Supports implementation and validation of new assays and new instrumentation.
  • Performs all quality control checks (monitor trends) on instruments reagents and techniques maintains quality control and calibration data.
  • Prepares and check reagents and supplies.
  • Performs calculations for work solutions or other calculations as required during experimental procedures.
  • Performs and documents required maintenance and calibration of laboratory instruments.
  • Maintains the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
  • Process samples for analysis or storage.
  • Utilize PIMS/LIS computer system for the processing of samples.
  • Collect biological samples from study subjects as needed.
  • Process samples for analysis and storage and oversee the specimen storage inventory.
  • Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
  • Train and or mentor personnel in laboratory procedures as assigned.
  • Perform data entry and monitor laboratory information system (LIS).
  • Maintain clean and safe work areas per SOP.
  • Write new or revise procedures for the SOP or Manuals as assigned.
  • May be assigned as an Instrument Key Operator when sufficient experience is demonstrated.
  • Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA COLA or CAP audits.
  • Will perform continuing education and EQA (external quality assessment)/ proficiency sample testing as assigned.
  • Monitors emails and voicemail to respond in an appropriate time frame.
  • Investigate any possible sample integrity issue and ensures that it is rectified.
  • Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits check-ins and discharges late.
  • Maintains open communication with other departments in the building and works as a team with Lab staff and CRU staff.
  • Responsible for accurate and timely national and/or international shipping of all NHPCRU samples.
  • Ensure all samples are packed for shipment in compliance with DOT and IATA regulatory agencies and company policy and procedures.
  • Maintain credential and certification for shipping of biohazardous materials nationally (DOT) and internationally (IATA).
  • Utilize PIMS Cerner and/or electronic notebooks for processing samples.
  • Monitor temperature sensitive equipment record deviations and provide corrective actions for temperature/humidity deviations.
  • Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA COLA or CAP audits.
  • Will cover off hours PK sample processing as needed.
  • Will cover Specimen Processor functions as needed.
  • Will do EQA (external quality assessment)/ proficiency sample testing as assigned for waived testing
  • Will bring any issue of noncompliance to the attention of Lab Quality Coordinator or the Lab Manager and act to rectify the situation.
  • Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits check-ins and discharges late.
  • Be able to function autonomously.
  • Perform critical problem solving

  BASIC QUALIFICATIONS

  • An Associates degree in Medical Technology is required Bachelors degree is preferred. MLT or MT certification is required for all individuals with a degree in Medical Technology.
  • Bachelors degree in chemical physical or biological science from an accredited college or university may be considered if educational requirements meet CLIA 88 standards for high complexity laboratories:
    • 16 semester hours of biology courses which are pertinent to medical sciences
    • 16 semester hours of chemistry (at least 6 hours of Inorganic Chemistry)
    • 3 semester hours of math
  • Minimum of 2 years of relevant work experience in pharmaceutical hospital or medical research is required.
  • Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
  • Working knowledge of Word applications.

  PREFERRED QUALIFICATIONS

  • Knowledge of clinical trials.
  • Knowledge of a pharmaceutical clinical research unit environment.
  • Working knowledge of GxP GCP CAP and CLIA regulations.
  • Demonstrates teamwork by effective participation in multifunctional teams motivate colleagues build relationships with customers and finding opportunities for collaboration.

  
  

  PHYSICAL/MENTAL REQUIREMENTS

  N/A

  NON-STANDARD WORK SCHEDULE TRAVEL OR ENVIRONMENT REQUIREMENTS

  Monday- Friday 7am - 3:30 pm and every third weekend rotation.

  Other Job Details:

  • Eligible for Relocation Package: NO
  • Eligible for Employee Referral Bonus: YES
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PHYSICAL/MENTAL REQUIREMENTS

Prolonged sitting and standing may occur.

Work Location Assignment:On Premise

The annual base salary for this position ranges from $66500.00 to $110900.00. In addition this position is eligible for participation in Pfizers Global Performance Plan with a bonus target of 7.5% of the base salary. We offer comprehensive and generous benefits and programs to help our colleagues lead healthy lives and to support each of lifes moments. Benefits offered include a 401(k) plan with Pfizer Matching Contributions and an additional Pfizer Retirement Savings Contribution paid vacation holiday and personal days paid caregiver/parental and medical leave and health benefits to include medical prescription drug dental and vision coverage. Learn more at Pfizer Candidate Site U.S. Benefits (). Pfizer compensation structures and benefit packages are aligned based on the location of hire. The United States salary range provided does not apply to Tampa FL or any location outside of the United States.

Relocation assistance may be available based on business needs and/or eligibility.

Research and Development

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