Have openings for 1st and 2nd shift positions.
- 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.
Education:
- 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.
Required Skills:
- 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.