Associate Quality Control Analyst (Virology)
Regeneron
East Greenbush, NY0–2 yrs9m agovia LinkedIn
About the Role
Regeneron is looking for an Associate Quality Control Virology Analyst. In this role you will be responsible for sample chain of custody, sample processing, testing and test data reporting and archiving.
- Work Schedule: Monday–Friday, 8:00am–4:30pm
- Location: East Greenbush, New York, United States
Key Responsibilities
- Ensure proper level of laboratory supplies and reagents and maintain laboratory in an audit readiness stage and cGMP compliant manner at all times.
- Perform routine and non-routine virus and mycoplasma testing (cell-based and molecular biology assays) of manufactured in-process commercial and clinical products according to cGMP and associated standard operating procedures.
- Review data for conformance to cGMP and specifications and assist with investigation of laboratory deviations.
- Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities.
- Apply basic and advanced troubleshooting methods.
- Serve as SME for an assigned assay.
- Assist in data trending, data review, and lab maintenance activities.
- Participate in non-routine projects.
- Apply knowledge to assist in investigations and support studies and protocols.
- Perform cell culture activities to support virus testing.
- Be responsible for collecting, entering data and generating reports from electronic systems.
- Always display good manufacturing practices (GMP) and good laboratory practices (GLP).
Requirements & Tech Stack
- Cell Biology
- Microbiology
- Biochemistry
- Cell culture
- Virus testing
- Mycoplasma testing
- cGMP
- GMP
- GLP
- Troubleshooting
- Electronic data systems
Qualifications
- A BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science.
- Experience working in a GMP virology or cell culture lab is strongly preferred.