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Analyst, QC II
Ref No.: 18-12742
Location: Novato, California
Performs, under direct or minimal supervision, molecular biological/physical/chemical analyses of test samples under cGMP to meet specified timelines.
Evaluates data against defined criteria/specifications.
Maintains the laboratory in an inspection-ready state.
Provides support for routine laboratory functions/chores for the QC laboratory.
Acts as a Product/Project Coordinator.
Interacts with other departments at BioMarin on a regular basis.
Develops and maintains proficiency in a broad range of trained test methods.
Assists in the revision of written procedures as assigned.
Assists in the preparation of routine and non-routine study protocols and reports.
Trains other Sr. Analysts in areas of expertise.
Seeks, learns, and applies new job related training and knowledge and shares knowledge with coworkers.
Holds self and others responsible to abide by department and company policies and practices. Is responsible for setting a good example for more junior Sr. Analyst in the department.
Develops familiarity concerning cGMP, 21CFR, USP, EP and ICH regulatory requirements.

Three 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.
Demonstrate strong leadership skills through past work history.
Identifies key issues in complex situations and analyzes problems and makes sound decisions.
Works independently as well in a team environment.
Familiarity with use of a computer: e.g., Proficient in Windows, Microsoft Word, Excel.
Good written, verbal, and communication skills.
Strong documentation skills a must.
The Sr. Analyst must develop skills in the operation and routine maintenance of various analytical instruments and computers. The Sr. Analyst must develop the skills necessary to understand the operation of the equipment and gain knowledge of the equipment used for testing and to use these skills in the event of an unexpected result caused by equipment or reagent failure that warrants a laboratory investigation.
Experience with cell based assays (i.e. infectious titer and transgene expression/ activity) using mammalian and insect cells, ELISA, qPCR, Western Blots, SDS-PAGE preferred.
Experience with separations technology for HPLC/UPLC such as Waters is preferred.
Experience with separations technology software such as Empower is preferred.
The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus.