The primary function of the High Throughput Clinical Testing (HTCT) team is to generate high-quality assay data in a regulated cGLP laboratory setting to support Pfizer's vaccine programs. The purpose of this position is to contribute to a harmonized process across HTCT functional areas in the development of written end-user requirements for data systems used in various laboratory processes, and testing of systems prior to validation and deployment in the Production environment.
* Assist in the Development of Laboratory Data Systems
* Contribute to a consistent, harmonized process across HTCT functional areas for the development of end-user requirements for various internal data systems used in the regulated cGLP laboratory space.
* Assist with end-user testing of various data system builds against end-user requirements to ensure that these systems function as intended by the end user.
* Collaborate with VRD Research Informatics personnel on data system projects according to VRD priorities.
* Attend regular meetings with HTCT functional area leaders to review and monitor various data system projects.
* Documentation Support
* Contribute to end-user requirements documents for various data system builds used in HTCT per the current good documentation practices.
* Review and approve various standard operating procedures (SOPs), as assigned.
* Maintain compliance with SOP periodic review process.
* Monitor the SOP review and approval workflows for authored SOPs.
* Author, review and approve technical reports, as assigned.
* Training and Safety
* Maintain strict compliance with departmental and site safety regulations.
* Take ownership of and successfully complete all assigned training.
* BS/BA in a science-related discipline such as Computer Science/Mathematics or Biological science with 0-2 years of industry experience is required.
* Must have strong verbal and written communication skills.
* Must be detail oriented
* Must have a be able to effectively describe laboratory and data-handling processes verbally and in writing in a way that is logical and can be understood by both data system specialists and laboratory personnel.
* Working knowledge of laboratory information management systems and a basic understanding / familiarity with SQL and computer programming.
* Experience with LabWare LIMS is desired.
* Familiarity with laboratory process flow charts and testable, line-item requirements is desired.
* Proficient in Microsoft Office 365 applications and MS Visio
* Strong attention to detail and commitment to operational excellence.
* Basic working knowledge of laboratory assays that measure antibodies and other macromolecules in various biological fluids.
* Ability to collaborate and work in a team environment
* Experience with a regulated (cGLP) environment.
* The ability to understand, develop and effectively describe complex laboratory and data-handling processes both verbally and in writing is required.
* Must be attentive to details and have a passion for data quality.
NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS
Occasional evening and weekend work and some business travel is required.
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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.
N (Other) (United States of America)
Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Pfizer is a research-based biopharmaceutical company engaged in the discovery, development, manufacture, and distribution of healthcare products.