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Quality Control Analyst

NKMax America Irvine, CA
  • Posted: over a month ago
  • $50,000 to $80,000 Annually
  • Full-Time
  • Benefits: Vision, Medical, 401k, Dental

Job Title
Quality Control Analyst

Job Summary
This role is to perform analytical testing in a cGMP environment

General Accountability
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.


NKMax America

Why Work Here?

Health changing products, entrepreneurial employees, great company culture, Team atmosphere & overall rewarding place to work

NKMax America, Inc. is a biomedical company specializing in autologous Natural Killer (NK) cell therapy, leveraging proprietary cell expansion and activation technology. NKMax America was created to bring life changing NK cell immunotherapy to the United States with a mission to improve patients' lives in a safe and natural way through innovative cell therapy products and to ultimately become the global leader in immune cell therapeutics.

Address

10 Pasteur, Ste.150, Irvine, CA 92618
Irvine, CA
USA

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