QC Analyst, qPCR and ELISA
Marin Metro Area, California
- Responsible for performing biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.
- Good record keeping, organizational, written, and verbal communication skills are essential.
- Must be willing to work overtime and weekends as required.
- Performs qPCR, ELISA and other molecular biology analyses of test samples under cGMP
- Evaluates data against defined criteria/specifications.
- Maintains laboratory supply inventories.
- Maintains mammalian and insect cell lines.
- Provides support for routine laboratory functions/chores for the QC laboratory.
- Develops and maintains proficiency in a broad range of trained test methods, mainly qPCR and ELISA.
- Potentially including: aseptic cell culture technique and gel electrophoresis.
- Assists in the revision of written procedures as assigned.
- Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- At least two years performing molecular biology techniques.
- Proficient in good pipetting techniques, handling micro volumes, and working with high throughput assay formats (96-well and above).
- At least two years in a cGMP/GLP laboratory quality control experience is preferred.
- Viral/gene therapy work experience is a plus.
- B.S./B.A. in a science major (biology/biochemistry/chemistry) with at least 2-3 years of qPCR, ELISA, and any other relevant laboratory experience.