The primary function of the High throughput Clinical Immunoassays and Diagnostics (HCID) 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 join the High throughput Business Analytics team to contribute to a harmonized process across HCID 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 HCID functional areas for the development of end-user requirements for various internal data systems used in the regulated cGLP laboratory space.
- Develop end-user requirements for data system builds requested by HCID functional area managers as well as for functional enhancements to existing builds.
- Assist and perform end-user testing of various data systems builds against end-user requirements to ensure that these systems function as intended by the end-user.
- Collaborate with Pfizer IT organizations on data system projects according to VRD priorities.
- Attend regular meetings with HCID functional area leaders to review and monitor various data system projects.
- Documentation Support
- Write and review end-user requirements documents for various data system builds used in HCID 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.
- MS/MA in a science-related discipline such as computer science/mathematics or biological science with 0+ years of hands-on industry experience with the development and testing of electronic data systems. Or BS/BA with at least 2 years of industry experience.
- Must have strong verbal and written communication skills.
- Must be detail-oriented
- Must have a be able to effectively describe complex 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.
- Direct hands-on experience with LabWare LIMS is desired.
- 1+ years’ experience as a Business Analyst in a corporate environment
- Must be able to describe laboratory processes in the form of flow charts and testable, line-item requirements.
- 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
- Direct hands-on experience working in a regulated (GCP) 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.
Occasional evening and weekend work and some business travel is required.
- Eligible for Employee Referral Bonus
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 they pay or reimburse, your name, address, and the number of payments made currently will be reported to the government.
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.
Information & Business Tech
- Salary Offer 0 ~ $3000
- Experience Level Junior
- Total Years Experience 0-5
- Dropdown field Option 1