QC Analyst - ELISA, qPCR
Marin Metro Area, California
- Performs, under direct or minimal supervision qPCR, ELISA and other molecular biology analyses of test samples under cGMP to meet specified timelines.
- Works independently on assays that he/she has mastered and under direct or minimal supervision for those assays that are more complex.
- 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.
- Trains other analysts in mastered techniques.
- Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Interacts with other departments, including but not limited to Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
- Required: At least two years performing molecular biology techniques. Proficient it:
- Proficient in good pipetting techniques
- handling micro volumes
- Working with high throughput assay formats (96-well and above).
- At least two years in a cGMP/GLP laboratory quality control experience is preferred.
- Ability to follow written instructions and to perform tasks with direct or minimal supervision.
- Familiarity with use of a computer; e.g., Proficient in Windows, Microsoft Word, Excel, LIMS.
- Viral/gene therapy work experience is a plus.
- Good written, verbal, and communication skills.
- Good documentation skills.
- Demonstrates the ability to work independently.
- 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.