Quality Control Analyst
Marin Metro Area, California
- The Quality Control Sr. Analyst, under minimal supervision, is responsible for writing and executing method validations. The Sr. Analyst will also be responsible for supporting biochemical, physical, and chemical evaluations of process development, lot release, and stability samples.
- 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