Analyst, QC I

1 Year

Novato, CA

Max PR: $27.21/hr

RESPONSIBILITIES

• Performs, under direct to minimal supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
• Evaluates data against defined criteria/specifications.
• Works independently on assays that they have mastered.
• Develops and maintains proficiency in a broad range of trained test methods.
• Trains other analysts in areas of expertise.
• Maintains the laboratory in an inspection-ready state.
• Maintains laboratory supply inventories.
• Ensures that support for glassware cleaning and other routine laboratory functions/chores for the QC laboratory are completed to meet business needs.
• Develop familiarity concerning cGMP, 21CFR, USP, EP, and ICH regulatory requirements.
• Interacts with other departments at BioMarin as appropriate.
• Holds self and others responsible to abide by department and company policies and practices.
• Assist in revision of written procedures as assigned.
• Other duties as assigned.

QUALIFICATIONS

• B.S./B.A. in Science (Major in Biology, Biochemistry, or Chemistry) with at least 2-3 years of relevant laboratory experience or A.S. with at least 4 years of relevant laboratory experience.
• 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 and Excel.
• Good written, verbal, and communication skills.
• Good documentation skills.
• Demonstrates the ability to work independently.
• Desired Skills:

At least one year in a cGMP/GLP laboratory; quality control experience is preferred.

Required

• LABORATORY
• QUALITY CONTROL
• DOCUMENTATION
• CGMP

Additional

• BIOCHEMICAL
• GLP
• MICROSOFT WORD
• EXCEL
• USP
• CHEMISTRY
• BIOCHEMISTRY
• ICH