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Laboratory Analyst (Medical Technologist)

Company

Pfizer
Address , New Haven, 06511, Ct
Employment type FULL_TIME
Salary
Expires 2023-07-02
Posted at 1 year ago
Job Description
Why Patients Need You
Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.
What You Will Achieve
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.
It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.
How You Will Achieve It
  • Maintains the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supply needs.
  • Will cover off hours PK sample processing as needed.
  • Process samples for analysis and storage and oversee the specimen storage inventory.
  • Utilize PIMS/LIS computer system for the processing of samples.
  • Performs calculations for work solutions or other calculations as required during experimental procedures.
  • Perform critical problem solving
  • Process samples for analysis or storage.
  • May be assigned as an Instrument Key Operator when sufficient experience is demonstrated.
  • Train and or mentor personnel in laboratory procedures as assigned.
  • Ensure all samples are packed for shipment in compliance with DOT and IATA regulatory agencies and company policy and procedures.
  • Will perform continuing education and EQA (external quality assessment)/ proficiency sample testing as assigned.
  • Performs routine and special clinical chemistry, hematological, coagulation, urinalysis, immunological and other tests according to the Standard Operating Procedures.
  • Utilize PIMS, Cerner and/or electronic notebooks for processing samples.
  • Performs all quality control checks (monitor trends) on instruments, reagents, and techniques, maintains quality control and calibration data.
  • Will bring any issue of noncompliance to the attention of Lab Quality Coordinator or the Lab Manager and act to rectify the situation.
  • Perform safety inspection of laboratories and surrounding office area as assigned and prepare a report.
  • Prepares and check reagents and supplies.
  • Be flexible with the schedule to cover inadvertent times that subjects/volunteers arrive for visits, check-ins, and discharges late.
  • Investigate any possible sample integrity issue and ensures that it is rectified.
  • Performs and documents required maintenance and calibration of laboratory instruments.
  • Perform data entry and monitor laboratory information system (LIS).
  • Collect biological samples from study subjects as needed.
  • Monitor temperature sensitive equipment, record deviations, and provide corrective actions for temperature/humidity deviations.
  • Monitors emails and voicemail to respond in an appropriate time frame.
  • Responsible for accurate and timely national and/or international shipping of all NHPCRU samples.
  • Maintain clean and safe work areas per SOP.
  • Will cover Specimen Processor functions as needed.
  • Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits.
  • Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits.
  • 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.
  • Write new or revise procedures for the SOP or Manuals as assigned.
  • Will do EQA (external quality assessment)/ proficiency sample testing as assigned for waived testing.
  • Maintain credential and certification for shipping of biohazardous materials nationally (DOT) and internationally (IATA).
  • Supports implementation and validation of new assays and new instrumentation.
  • Be able to function autonomously.
Qualifications
Must-Have
  • 3 semester hours of math
  • Demonstrates teamwork by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.
  • 16 semester hours of biology courses, which are pertinent to medical sciences.
  • Working knowledge of GxP, GCP, CAP and CLIA regulations.
  • 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
  • Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
  • Bachelor’s degree is required. MLT or MT certification is required for all individuals with a degree in Medical Technology.
  • 16 semester hours of chemistry (at least 6 hours of Inorganic Chemistry)
  • Knowledge of clinical trials.
  • Working knowledge of Word applications.
  • Minimum of 3 years of relevant work experience in pharmaceutical, hospital, or medical research is required.
  • Knowledge of a pharmaceutical clinical research unit environment.
Nice-to-Have
  • Master degree is preferred.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Monday - Friday 8:30 am to 5:00 pm very 4th weekend
Other Job Details:
  • Last Date to Apply for Job: 11 MAY 2023
  • Eligible for Employee Referral Bonus
  • Not eligible for Relocation Assistance
Work Location Assignment: On Premise
On Premise colleagues work in a Pfizer site because it’s needed to get their job done. They may have flexibility to work remotely from time to time, but they are primarily on-site.
Relocation assistance may be available based on business needs and/or eligibility.
Sunshine Act
Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider’s name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative.
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