QC Sr. AssociateLocation Novato, California Apply
BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin’s cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Come join our team and make a meaningful impact on patients’ lives.
The Quality Control Sr. Associate , under moderate supervision, is responsible for performing biochemical, physical, and chemical evaluations of release, stability, non-routine, investigative, and validation samples.
This position requires willingness to undergo training on applicable analytical methods and safety policies. Work assignments will encompass performing and documenting activities from routine to non-routine in nature, and require the ability to recognize deviations from the accepted practice. Good record keeping, organizational, written and verbal communication skills are essential.
- Perform, under direct supervision, biochemical/physical/chemical analyses of test samples under cGMP to meet specified timelines.
- Evaluate data against defined criteria/specifications.
- Maintain laboratory supply inventories.
- Maintain the laboratory in an inspection-ready state.
- Develop proficiency in a limited number of tests.
- Timely complete of assignments.
- Sr Analyst- At least 4 years’ experience, cGMP/Quality Control experience preferred
- Associate I- At least 6 years’ experience, cGMP/Quality Control experience preferred.
- Ability to follow written instructions and to perform tasks with moderate (Sr Analyst) to minimal (Associate) supervision.
- Familiarity with use of a computer (e.g., Proficient in Windows, Microsoft Word, Excel, Typing).
- Good written and verbal skills.
- Strong record keeping skills
- Expertise in several of the following method types: HPLC (RP, SEC, SCX, peptide map, etc), ELISA, cellular uptake, enzymatic activity, dye ingress, and Capillary Electrophoresis.
- Sr Analyst: B.S./B.A. in a scientific discipline with 4+ years of relevant laboratory experience or A.S. with at least 6 years of relevant laboratory experience.
- Associate I: B.S./B.A. in a scientific discipline with 6+ years of relevant laboratory experience or A.S. with at least 8 years of relevant laboratory experience.
Experience with at least some of the following equipment required: Spectrophotometer, HPLC (Waters preferred), CE, iCE3, Dionex, Zwick, Vacuum Decay.
Reports to Quality Control Scientist 1I. Interacts with several departments, including but not limited to Analytical Chemistry, Quality Assurance, Regulatory, Process Development, Manufacturing Maintenance, and Engineering.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.