United States onlyJOB DESCRIPTION: Perform routine and non-routine release, in-process and stability testing for drug substance, drug product, and other critical reagents and documentation under cGMP. Perform Analytical assays such as ELISA, SDS-PAGE, Western Blot, Water Content, UV, Appearance, and pH. Author quality records such as Deviation, Lab Investigations, CAPA, Change Control including leading thorough and timely investigation and/or implementation activities. Author/ revise SOPs. Review of laboratory records generated in support of QC testing including procedures, methods, audit trails and other controlled documents. Compile and review data to ensure accuracy and regulatory compliance. Support sample receiving, shipment to contract lab and inventory of sample. Work collaboratively with Manufacturing, QA and Regulatory to support CMC analytical deliverables. Wage $90,000.00 - $105,000.00 per year. Telecommuting is permitted.
REQUIREMENTS: Master's or foreign equivalent degree in Biotechnology, Bioinformatics, or a related science
Must have work/internship experience or completed graduate coursework/research in each of the following:
- Analytical techniques such as ELISA, Western Blot, Karl Fisher, pH, and Appearance.
- Quality Control laboratory environment.
- Working with biological products in a GMP environment.
- Working with US and international (such as EU, ICH, GXP) regulations and guidance applicable to drug substance and drug products.
- Microsoft Office, LIMS system, and data trending.
- Data Integrity principles.
TO APPLY, please send your resume to human.resources@revance.com and refer to this posting. EOE.
AU, CA + 8 more