Quality Control Analyst – FT – Santa Ana, CA

Job Summary

This role is to perform analytical testing in a cGMP environment

General Accountabilities

This position is responsible for the following:

  • Conduct biological, chemical and physical analyses of raw materials, in-process and final product samples to support manufacturing, validation, process development and stability studies in a GMP environment.
  • Use sophisticated laboratory instrumentation and computer systems to collect and record data (such as LIMS system).
  • Perform assays requiring precise analytical skills and understanding of biology and chemistry principles.
  • Complete testing in a timely and appropriate manner.
  • May maintain inventory/supplies necessary to conduct routine testing
  • Performs equipment maintenance and calibrations as required.
  • Perform aseptic sampling, visual inspection, gowning and working in clean room areas.
  • Review, revise and write test methods, standard operating procedures. In addition to performing QC testing, the Analyst may support validation projects, investigations and method development projects.
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR and cGMP regulations. Perform release functions in LIMS or other computerized systems.
  • Investigate and write exception (e.g. deviations and OOS) documents.
  • May perform other duties as assigned.

Job Qualifications and Skills:

  • Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 2-5 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 0-3 years experience.
  • Working knowledge of GMP quality systems, regulatory requirements, relevant pharmacopeia and guidance documents.
  • Experience with FACS, ELISAs, PCR, FTIR, UV and Fluorescence spectroscopy, and other applicable methods to the testing of biopharmaceuticals.
  • Experience with setting up and successfully managing cell-based assays is highly preferred.
  • Education, training, or experience in cell therapy a plus.
  • Proficient in MS Office, Visio, Project, and statistical software.
  • Ability to effectively work in a fast-paced, start-up environment, while dealing with ambiguity.
  • Strong attention to detail with the ability to multi-task and handle multiple responsibilities simultaneously.
  • Excellent organizational skills and an ability to prioritize effectively to deliver results within reasonably established timelines.
  • Ability to work independently and as part of a team.
  • Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
  • Candidates must be authorized to work in the U.S.