Senior Regulatory Science Technician

2 weeks ago


Fremont, United States Comrise Full time

*** This is a 24-month contract position with a high possibility of extension ***


POSITION: Senior Regulatory Science Technician

DURATION: 24-month contract

LOCATION: 47900 Bayside Pkwy Fremont, CA

WORK-SET UP: Onsite | 8:00 AM to 5:00 PM

PAY: $30 to $32/hour in W2


Overview

  • Assists in developing and validating testing methodology used to control raw materials, production intermediates and final products.
  • Helps establish, validate and document new or existing compound identification methods.
  • May conduct testing of analytical samples for the laboratory area, the separation and characterization of protein drug candidates, formulation development, peptide mapping and other analytical methods of development.
  • Conducts work in compliance with cGMP, safety and regulatory requirements. May provide analysis and evaluation of material and products at all stages of development process.
  • This position requires knowledge that is acquired through experience, specialized education, or training.
  • The role has clearly defined procedures and tasks as well as defined guidelines to aid in decision making.
  • The job should possess a good knowledge and comprehensive understanding of the range of processes, procedures and systems to be used in carrying out assigned tasks and a basic understanding of the underlying concepts & principles upon which the job is based.
  • The knowledge can be acquired through a combination of job-related training and considerable on-the-job experience.
  • The job works within well-defined procedures that may involve a variety of work routines.
  • This job typically requires a minimum of 3 or more years experience.
  • The majority of this role involves the understanding and operation of FTIR spectroscopy, Inductively coupled plasma mass spectrometry (ICP-MS), X-ray fluorescence (XRF), and UV-Vis spectroscopy and will also employ gravimetric analysis.
  • Additional analytical chemistry tests may be conducted based on the needs of the business.



send your updated resume to sam.santos@comrise.com



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