Analyst, QC I

TapTalent.ai


Date: 17 hours ago
City: Novato, CA
Contract type: Full time
We're Hiring: Analyst, QC I!

We are seeking a detail-oriented and analytical Analyst, QC I to join our quality control team. The ideal candidate will have experience in quality assurance processes and a strong understanding of regulatory compliance within the industry.

Job Description

Fully On Site (Monday – Friday 8-5 p.m.)

  • 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.

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.

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

Additional Information:

  • LABORATORY
  • QUALITY CONTROL
  • DOCUMENTATION
  • CGMP

Additional

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

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