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NKMax America Inc

Quality Control Analyst

QCA · Santa Ana, California
Department QCA
Employment Type Full-Time
Minimum Experience Mid-level

Job Summary

NKMax America is seeking a Quality Control Analyst to perform analytical testing in a cGMP environment. 

General Responsibilities:

- 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.

- Provide training to junior staff.

- May perform other duties as assigned.

 

Position Requirements & Experience:

- Bachelors Degree in Chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 3-6 years experience, or Masters Degree in Chemistry, or Biological Sciences, with 2-5 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. and agree to a background check

 

 

 

 

 

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  • Location
    Santa Ana, California
  • Department
    QCA
  • Employment Type
    Full-Time
  • Minimum Experience
    Mid-level