Analyst, QC 1
San Rafael, California | Contract
Our focus is on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases.
- Participates in product/project coordination internally, and with outside laboratories.
- Manages shipments (inventory, packaging, documentation, and coordination) to partner laboratories.
- Maintains laboratory supply inventories, and preparation for critical reagents.
- Manages data trends for critical reagents and reference material.
- Maintains the laboratory in an inspection-ready state.
- Provides support for routine laboratory functions/chores for the QC laboratory.
- Assists in the preparation/revision of routine and non-routine study protocols and reports and qualification documents.
- Trains other analysts in areas of expertise on basic assays as well as more complex assays that are mastered.
- Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.
- Interacts with other departments, including but not limited to Shipping, Regulatory, Manufacturing, Microbiology, Quality Assurance, Analytical Chemistry, Formulation, and Process Development.
- Performs, under direct or minimal supervision, biochemical/physical/chemical 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.
- At least one year in a cGMP/GLP laboratory; quality control experience is p
- 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.
- Experience with bioassay and/or HPLC techniques.
- Good written, verbal, and communication skills.
- Good documentation skills.
- Demonstrates the ability to work independently
- Detail oriented and organized
- Ability to multitask
Education: B.S./B.A. in Science (major in biology-biochemistry-chemistry) with at least 1 year of relevant laboratory experience or A.S. with at least 2 years of relevant laboratory experience.