Pfizer Laboratory Analyst & Project Coordinator in New Haven, Connecticut
As a Safety Laboratory Analyst, 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). Responsibilities will also include: quality control, validation of new assays, new employee training, documentation, own training, instrument owner duties, laboratory equipment use, calibration, maintenance, inventory and sample processing.
As a Laboratory Coordinator, the individual will assist in clinical trial study set-up activities and data cache (study QC and reconciliation of issues) at study closeout, as assigned by the Laboratory Coordinator Lead. Works with PCRU study team members or Biomarker Leads to execute clinical trials or external biomarker development that meet regulatory guidelines, project team timelines, and quality requirements.
May serve as a back-up for specimen processing and sample shipping as required.
May serve as a back-up for analysis of Biomarker specimens.
Serves as an expert to troubleshoot laboratory-based issues that arise in the preparation, conduct, close-out of clinical trials.
Provides novel approaches to resolving problems and issues that may arise within the Safety or Biomarker Laboratories during assay conduct
Perform all routine and special clinical chemistry, hematological, coagulation, and urinalysis, immunological and other tests according to the Standard Operating Procedures.
Implement and validate new assays. May assist with assay development. Coordinates with the guidance of the Laboratory Manager new methods validation and instruments implementation.
Performs all quality control checks (monitor trends) on instruments, reagents, and techniques, maintain quality control andcalibration data.
Prepare and check reagents and supplies. Perform calculations for work solutions or other calculations as required duringexperimental procedures.
Perform and document required routine maintenance and calibration of laboratory instruments.
Maintain the inventory of and order laboratory supplies including notifying instrument key operators of upcoming reagent/supplyneeds.
Process samples for analysis or storage.Utilize PIMS/LIMS computer system for the processing of samples.
Collect biological samples from study subjects. Process samples for analysis and storage. 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.
Instrument Owner: Performs monthly QC report and reviews with Laboratory Quality Coordinator.Maintains reagent and consumable inventory.Performs lot to lot QC comparison and sets QC ranges.Schedules preventative maintenance.Monitors that maintenance is performed.Reviews SOPs yearly for relevance and documents review.
Assists the Laboratory Manager with the Laboratory Quality Coordinator and Improvement Plan by identifying pertinent quality goals, plans and procedures for measuring and monitoring quality, procedures for responding to insufficient quality and for improving quality by documentation and development. Implementation of Corrective Actions/ Preventive Actions /Immediate Actions if needed.
Assist the Laboratory Quality Coordinator with preparation for Internal audits and CLIA, COLA or CAP audits.
Performs Biomarker testing as assigned.QC and analyze the data produced from analysis.Document all analysis on appropriate assay check sheets.
Will perform continuing education as assigned
Will do EQA (external quality assessment)/ proficiency sample testing as assigned
Will bring any issue of noncompliance to the attention of Lab Quality Coordinator or the Lab Manager and act to rectify the situation.
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.
Open communication with other departments in the building • Work as a team with Lab staff and CRU staff
Be able to function autonomously.
Perform critical problem solving
Any additional projects assigned by the supervisor.
Coordinates laboratory projects with all customers (organizes laboratory project meetings, ensures clarity of laboratory procedures) and organizes laboratory project planning and budget for PCRU clinical studies as assigned by Laboratory Coordinator Lead. Assures that planning and decision-making positively impact conduct of studies at the PCRU.
Resolves laboratory-based problems that occur in study protocols. Has effective decision-making abilities that allows developing new options for complex problems.
Minimum of a Bachelor's Degree in Medical Technology.
Minimum of 3+ years of relevant work experience in pharmaceutical, hospital, or medical research.
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
American Society of Clinical Pathology (ASCP) certified. Will consider individual without certification if they meet all other requirements.
Knowledge of clinical trials a plus.
Working knowledge of GxP, GCP, CAP, and CLIA regulations.
Working knowledge of computers and laboratory data handling acquisition systems and associated issues/risks.
Working knowledge of Word applications.
5 years of relevant work experience in pharmaceutical, hospital, or medical research.
Understanding and demonstrated proficiency in handling laboratory projects.
Knowledge of a pharmaceutical clinical research unit environment.
Demonstrated understanding of the complexities and recent developments in Biomarker research.
Ability to challenge existing paradigms in clinical research and to encourage novel designs/ideas and research approaches to improve study conduct, data capture, retrieval and submission processes.
Demonstrates team work by effective participation in multifunctional teams, motivate colleagues, build relationships with customers, and finding opportunities for collaboration.
Other Job Details:
Last Date to Apply for Job: May 19th 2020
Additional Location Information: New Haven, CT
Eligible for Employee Referral Bonus
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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