Job Description
Job Description
NKGen Biotech 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
Job Qualifications & Skills
- Bachelor’s Degree in chemistry, or Biological Sciences with Analytical Chemistry or Laboratory coursework, with 3-6 years’ experience, or Master’s degree in Chemistry, or Biological Sciences, with 2-5 years’ experience.
- Candidates must be authorized to work in the U.S. and agree to a background check.
- 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.
- Off hours or weekend work will be required at times dependent upon the needs of the company
B enefits & Perks
- Competitive compensation
- Medical, Dental and Vision Insurance
- Business casual work attire
- Fully stocked kitchen and much more!
23 days ago