Quality Assurance Analyst II

1 week ago


Santa Ana, California, United States NKGen Biotech Full time
Quality Control Analyst at NKGen Biotech

NKGen Biotech is seeking a Quality Control Analyst to perform analytical evaluations within a cGMP framework.

Key Responsibilities:

  • Conduct biological, chemical, and physical assessments of raw materials, in-process, and final product samples to support manufacturing, validation, process development, and stability studies in a GMP setting.
  • Employ advanced laboratory instruments and computer systems to gather and document data accurately.
  • Execute assays that necessitate meticulous analytical capabilities and a solid understanding of biological and chemical principles.
  • Complete testing efficiently and within established timelines.
  • May oversee inventory management and carry out equipment maintenance and calibration as required.
  • Perform aseptic sampling, visual inspections, gowning, and operate in cleanroom environments.
  • Review, modify, and compose test methodologies and standard operating procedures.
  • Ensure adherence to company SOPs, FDA regulations, GLP, QSR, and cGMP standards.
  • Investigate and document exceptions as necessary.

Qualifications:

  • Bachelor's degree in Chemistry or Biological Sciences with relevant Analytical Chemistry/Laboratory coursework and 3-6 years of experience, or a Master's degree with 2-5 years of experience.
  • Proficient understanding of GMP quality systems, regulatory standards, and applicable pharmacopeia.
  • Experience with diverse testing methodologies including FACS, ELISAs, PCR, FTIR, UV, and Fluorescence spectroscopy.
  • Competence in MS Office, Visio, Project, and statistical analysis software.
  • Ability to thrive in a dynamic, start-up atmosphere while managing multiple tasks concurrently.
  • Excellent interpersonal skills with the capacity to work both independently and collaboratively.
  • Flexibility to work during off-hours or weekends as needed.

Benefits:

  • Competitive salary
  • Comprehensive Medical, Dental, and Vision Insurance
  • Business casual dress code
  • Fully stocked kitchen and additional perks


  • Santa Ana, California, United States NKGen Biotech Full time

    Quality Control Analyst at NKGen BiotechNKGen Biotech is seeking a dedicated Quality Control Analyst to perform analytical evaluations within a cGMP framework.Key Responsibilities:Conduct biological, chemical, and physical assessments of raw materials, in-process, and final product samples to support manufacturing, validation, process development, and...


  • Santa Ana, California, United States NKGen Biotech Full time

    Quality Control Analyst at NKGen BiotechNKGen Biotech is seeking a Quality Control Analyst to perform analytical evaluations within a cGMP framework.Key Responsibilities:Conduct biological, chemical, and physical assessments of raw materials, in-process, and final product samples to support manufacturing, validation, process development, and stability...


  • Santa Ana, California, United States RICAURTE PRECISION INC Full time

    Job OverviewThe Quality Control Analyst plays a crucial role in the establishment and maintenance of the organization's Quality Management System (QMS). This position is essential for enhancing operational efficiency through the strategic planning and execution of Continuous Improvement initiatives. The Quality Control Analyst aids in the daily management of...


  • Santa Ana, California, United States UHSM Unite Health Share Ministries Full time

    Job OverviewUnite Health Share Ministries (UHSM) is a nonprofit organization dedicated to facilitating health sharing among Christian families. Our mission is to foster a supportive community that promotes holistic health and well-being. We are currently seeking a qualified individual for the role of Call Center Quality Analyst.Role SummaryThe Quality...


  • Santa Ana, California, United States EFP Staffing Full time

    Job OverviewWe are looking for a dedicated Quality Assurance Specialist to enhance our operations. In this role, you will perform assessments to evaluate the quality of materials and end products while pinpointing opportunities for enhancement to boost productivity.Key Responsibilities:Conduct comprehensive inspections of all materials and finished...


  • Santa Ana, California, United States Jobot Full time

    Seeking a skilled Quality Engineer to enhance our quality assurance initiativesAbout Us:We are a leading firm specializing in the development of advanced digitally assisted mixed-signal RF components. Our innovative products are designed for high-performance applications, including precision timing solutions, high linearity data converters, FMCW chirp radar...


  • Santa Ana, California, United States KPC GLOBAL MEDICAL CENTERS INC. Full time

    Join Our Team as a Quality Assurance SupervisorPOSITION SUMMARY:KPC GLOBAL MEDICAL CENTERS INC. is in search of a committed Quality Assurance Supervisor to lead and improve the functions of our Quality department. In this role, you will be tasked with executing performance enhancement strategies, ensuring compliance readiness, and reducing potential risks...


  • Santa Ana, California, United States Jobot Full time

    Seeking a skilled Quality Engineer to enhance our quality assurance effortsAbout Us:We are a leading firm specializing in the development of advanced mixed-signal RF components. Our innovative products are designed for high-performance applications, including precision timing, high linearity data converters, FMCW chirp radar transceivers, and efficient power...


  • Santa Ana, California, United States Jobot Full time

    Seeking a skilled Quality Engineer to enhance our quality assurance initiativesAbout Us:We are a leading firm specializing in the development of advanced mixed-signal RF components. Our innovative products serve high-performance applications including timing solutions, data converters, FMCW radar transceivers, and efficient power amplifiers, ensuring...


  • Santa Ana, California, United States Jobot Full time

    Seeking a skilled Quality Engineer to enhance our quality assurance initiativesAbout Us:We are a leading firm specializing in the design and production of advanced mixed-signal RF components. Our innovative solutions are tailored for high-performance applications, including precision timing, linear data conversion, FMCW radar systems, and efficient power...


  • Santa Clara, California, United States Roche and Genentech Full time

    Job OverviewPosition Summary:The Senior Quality Assurance Analyst is responsible for the development and execution of a robust Quality Management System (QMS) that adheres to FDA Quality System Regulation (QSR) and International Standards Organization (ISO) standards, as well as Roche corporate policies.Key Responsibilities:Facilitate the implementation of...


  • Santa Ana, California, United States Aspire Bakeries Full time

    Job OverviewAspire Bakeries stands as a premier baking entity in North America, focusing on frozen baked products. Our extensive range includes items such as breads, cookies, donuts, and more, reflecting our commitment to innovation and customer satisfaction. Our foundational values—Integrity, Ownership, Customer Focus, Creativity, and Care—guide our...


  • Santa Ana, California, United States Jobot Full time

    Job SummaryWe are seeking an experienced Quality Engineer to join our team at Jobot. As a Quality Engineer, you will be responsible for ensuring the quality of our products and services, collaborating with customers to understand and meet quality requirements, and maintaining and improving our Quality Management System (QMS).Key ResponsibilitiesCollaborate...


  • Santa Ana, California, United States Nihon Kohden Orange Med Full time

    Job SummaryWe are seeking a highly skilled Quality Assurance Specialist to join our team at Nihon Kohden Orange Med. As a Quality Assurance Specialist, you will play a critical role in ensuring the efficient and compliant operation of our Quality Management System (QMS).Key ResponsibilitiesPost Market SurveillanceCollaborate with cross-functional teams to...


  • Santa Ana, California, United States G.A.S. Global Full time

    Job SummaryWe are seeking a skilled Production Technician to join our team at G.A.S. Global. As a key member of our production team, you will be responsible for ensuring the quality and safety of our products.Key ResponsibilitiesConduct thorough testing and inspection of products to ensure compliance with quality and safety standards.Investigate and analyze...


  • Santa Ana, California, United States RBC Bearings Incorporated Full time

    About the RoleRBC Bearings Incorporated is seeking a skilled Aerospace Quality Inspector to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the highest standards of quality in our precision bearings and components.Key ResponsibilitiesInspect and Test Products: Use gauges and basic hand tools to inspect...


  • Santa Ana, California, United States Aspire Bakeries Full time

    Job SummaryAspire Bakeries is a leading North American baking company with a strong presence in the specialty frozen baked goods market. We are committed to driving innovation, predicting consumer trends, and exceeding customer expectations. As a key member of our Food Safety and Quality Assurance team, the FSQA Quality Assurance Technician plays a critical...


  • Santa Ana, California, United States eTeam Full time

    Job SummaryeTeam is seeking a skilled Production Test Technician to join our team. As a key member of our production team, you will be responsible for testing and validating the performance of manufactured products, ensuring they meet our high standards of quality and safety.Key ResponsibilitiesConduct thorough testing of products to ensure they meet...


  • Santa Ana, California, United States Vaco Full time

    Join Our Team as a Quality Assurance SpecialistA reputable food production organization is actively seeking a Quality Assurance Specialist to enhance our operations. This position offers a long-term temporary opportunity with the potential for permanent placement after a specified period.Why Choose Us?Our company is dedicated to providing a stable work...


  • Santa Ana, California, United States Pioneer Circuits Inc. Full time

    Job DescriptionAbout Pioneer Circuits Inc.Pioneer Circuits Inc. is a leading manufacturer of innovative high-performance flexible circuit boards, dedicated to the design, production, and assembly of advanced printed circuit board assembly (PCBAs) technology solutions.We develop cutting-edge solutions that explore new frontiers, serve and protect our armed...