Senior Medical Technologist
Leads and/or supports the delivery of quality Safety Laboratory (Clinical Pathology) sample testing and data reporting as an integral member of Pfizer Clinical Research Unit (PCRU) Safety Laboratory. Primary sections of focus include Hematology, Coagulation, Clinical Chemistry, Urinalysis, but many include other laboratory areas. Responsible for problem resolution, quality control, and required equipment maintenance and vendor interactions within specialty sections. Maintains effective communication and working relationships with all laboratory personnel, other PCRU disciplines, including medical providers. Participates and/or leads laboratory projects and educational activities. Demonstrates and educates laboratory principles and technical skills to others, can think analytically and critically, and works independently. May direct and coordinate a small group of Technologists (generally 8 or fewer) in the absence of the Laboratory Supervisor and carry out supervisory functions. Meets the requirements to serve as either Testing Personnel or Technical Supervisor for high complexity laboratories as defined by CLIA regulations
- The Senior Medical Technologist is a subject matter expert for routine, non-routine and highly complex clinical pathology assays within the New Haven PCRU laboratory.
- Serve as technical expert for hematology, coagulation assays, and chemistry assay conduct. Solves complex and ambiguous problems associated with sample testing for clinical trials.
- Prepares continuing education in area(s) of expertise to help train and mentor staff.
- Supports conduct of specialized coagulation testing, including mechanical clot-based assays, chromogenic assays, and ELISA testing.
- Helps develop and validate non-routine chemistry assays.
- Performs all routine and special clinical chemistry, hematology, coagulation, urinalysis, and immunological tests according to Standard Operating Procedures. Identifies and develops scientific goals to meet hematology and coagulation goals.
- Evaluates quality control and contributes to generation of quality assurance reports of pre-analytic, analytic, and post-analytic processes within the laboratory.
- Works with Lab Quality Coordinator to evaluate external quality control and proficiency reports. Assists in CAP/COLA and CLIA inspection processes.
- Implement and validate new assays. Writes validation reports.
- Provides technical direction to other staff and contracted resources for assay conduct and instrumentation usage.
- Uses scientific judgment and previous experience to investigate and resolve analytical testing problems and recommend course of action.
- Assume the daily direction of the laboratory in the absence of the Safety Manager.
- Functions independently. Proactively gathers information and input to complete projects.
- Effectively communicates (both orally and written) within Lab and PCRU.
- Sound decision-making skills that provide positive impact on PCRU project teams.
- Bachelor’s degree in a chemical, physical, biological or clinical laboratory science or medical technology with at least one year of training and or experience in high complexity testing or Associate degree in a laboratory science or medical technology with at least two years of experience and or experience in high complexity training.
- 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.
- Certified by one of the following accrediting agencies: MT (ASCP), MLS (ASCP) or categorical MT(NCA), MT(AMT), MT(HHS or HEW).
- Minimum of six years clinical laboratory experience with an emphasis on hematology and coagulation testing.
- Working knowledge of all sections of clinical pathology (chemistry, hematology, coagulation, urinalysis, drug screening, point-of-care testing) with 10+ years overall experience.
- Experience with high complexity coagulation testing including ELISA testing.
- Experience with normal and abnormal hematology cytograms.
- Experience with instrument validation, maintenance, calibration and QC requirements.
- Strong knowledge of medical technology applications and the willingness and mindset to train others.
- Knowledge of CLIA, CAP and GxP regulatory requirements.
- Experience with CAP, CLIA and/or JCAH audits.
- Self-driven with accountability and quality mindset.
- Experience with Laboratory Information Systems for data capture.
- Management or supervisory experience a plus.
- Reports to Safety Manager in the New Haven, CT PCRU.
- Safety Laboratory point of contact for Pfizer Inc laboratory equipment and supply vendors, and contracted resource agencies relevant to hematology and/or coagulation conduct.
- Matrixed relationship with Biomarker Group, Clinical Services, Medical Providers, Recruitment, Finance, Data Systems, Pharmacy and Clinical Operations within the PCRU.
- Ability to stand for periods of time while performing analysis.
- Ability to perform mathematical calculations.
- Ability to perform data analysis and interpret complex data cytograms.
Additional Posting Information
- Eligible for Employee Referral Program: Yes