Quality Control Analyst
Marin Metro Area, CA
- Perform, under minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines. Work independently on assays that he/she has mastered.
- Evaluate data against defined criteria/specifications.
- Maintain laboratory supply inventories.
- Maintain the laboratory in an inspection-ready state.
- Provide support for routine laboratory functions/chores for the QC laboratory.
- Develop and maintain proficiency in a broad range of test methods.
- Assist in the revision of written procedures as assigned.
- Assist in method validations, protocol, and report writing.
- Familiarity with cGMP, 21CFR, USP, EP, and ICH regulatory guidance
- At least one year 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,
- Good written, verbal, and communication skills.
- Strong documentation skills.
- MUST HAVE experience in at least one of the following techniques for peptide or protein products:
- capillary electrophoresis
- HPLC- RP
- ion exchange
- peptide map
- Analyst II Bachelor s Degree in science (major in biology-biochemistry-chemistry) with at least 2-3 years
- Senior Analyst Bachelor s Degree in science (major in biology-biochemistry-chemistry) with at least 5-6 years