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 Associate's degree in Medical Technology is required, Bachelor's degree is preferred. MLT or MT certification is required for all individuals with a degree in Medical Technology.
• Bachelor's 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 8am - 4:30 pm and every third weekend rotation.

Other Job Details:

• Eligible for Relocation Package: NO
• Eligible for Employee Referral Bonus: YES
• #LI-PFE

Pfizer requires all U.S. new hires to be fully vaccinated for COVID-19 prior to the first date of employment. As required by applicable law, Pfizer will consider requests for Reasonable Accommodations.

Sunshine Act

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EEO & Employment Eligibility

Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer.

Research and Development