Quality Control Analyst Applied StemCell, Inc. - 3.3 Milpitas, CA Job Details Full-time $80,000 - $110,000 a year 16 hours ago Benefits Health savings account Health insurance Dental insurance 401(k) Flexible spending account Paid time off Vision insurance Life insurance Qualifications Biology Biochemistry Bachelor's degree Attention to detail Organizational skills Full Job Description About Applied StemCell Applied StemCell (ASC) is a genome engineering platform company advancing the future of genetic and cell-based medicine through its proprietary TARGATT™ and S-SELeCT™ technologies. These innovations enable safe, scalable, site-specific integration of large payloads with reliable gene expression for the development of next-generation therapies, both ex vivo and in vivo. With deep expertise in induced pluripotent stem cells (iPSCs) and cell line engineering, ASC provides end-to-end solutions that accelerate innovation across academia and biopharma. Our strong IP foundation and cutting-edge technologies empower partners to move from concept to clinic with precision, scalability, and confidence. Please visit www.appliedstemcell.com for more information. Position Overview Applied StemCell is seeking an experienced and highly motivated Quality Control Analyst to join our Quality Control (QC) team. This position supports the quality and compliance of our products through the execution of analytical testing and support of method qualification, validation, transfer, release, and stability activities for cell and gene therapy products in a cGMP-regulated environment.

Work Location:

Milpitas, California (Onsite) Key Responsibilities Execute and support the development, qualification, validation, and transfer of analytical methods used for characterization, release, and stability testing of cell and gene therapy products. Perform routine QC testing in accordance with approved methods, SOPs, and cGMP requirements; accurately document and interpret test results and troubleshoot analytical issues as they arise. Support batch release activities including . Support analytical method transfers from clients and internal departments, including method assessment, execution, documentation, and implementation within QC operations. Collaborate closely with other departments, including Product Development and Manufacturing, to support the analytical needs of ongoing projects. Draft, revise, and review QC documentation, including test methods, protocols, reports, SOPs, worksheets, and method qualification/validation documentation, in accordance with cGMP requirements. Participate in laboratory investigations, including out-of-specification (OOS), out-of-trend (OOT), deviations, and CAPA activities, and assist with root cause and corrective action documentation. Stay current with industry trends and regulatory requirements related to analytical development and quality control of cell and gene therapy products.

Desired Qualifications :

Minimum of 5 years of relevant laboratory experience, including experience in a cGMP-regulated biotechnology, pharmaceutical, or CDMO environment; cell and gene therapy experience is preferred. Hands-on experience with analytical methods such as qPCR/ddPCR, ELISA, flow cytometry, cell-based assays, or other molecular and cellular biology techniques used for biologics or cell and gene therapy products. Working knowledge of cGMP requirements and applicable FDA and ICH guidance related to QC testing, analytical methods, documentation, and data integrity. Experience with analytical troubleshooting, data analysis, and interpretation. Excellent communication skills and the ability to work effectively in a multidisciplinary team environment. Strong organizational skills and attention to detail.

Preferred Qualifications:

Experience with analytical method qualification, validation, transfer, or comparability studies. Experience with mammalian cell culture, iPSC technologies, genome engineering, or cell-based assays. Familiarity with statistical analysis software (e.g., JMP, Minitab). Technical Skills The successful candidate should possess experience or working knowledge in the following areas:

• Analytical Testing - Hands-on experience with molecular, cellular, and immunoassay-based testing techniques such as qPCR/ddPCR, ELISA, flow cytometry, and cell-based assays, including accurate execution, data analysis, and troubleshooting.
• QC Laboratory Operations - Experience performing testing in a cGMP-regulated laboratory, including sample handling, preparation and use of reagents and standards, instrument operation, contemporaneous documentation, data review, and adherence to approved methods and SOPs.
• Quality Systems & Compliance - Working knowledge of cGMP requirements, Good Documentation Practices (GDP), data integrity, laboratory investigations, OOS/OOT, deviations, CAPA, change control, and controlled QC documentation.

Education:

Bachelor's degree in Analytical Chemistry, Biochemistry, Biology, or a related scientific discipline; an advanced degree is a plus. This job description in no way states or implies that these are the only duties to be performed by this employee. He or she will be required to follow any other instructions and perform any other duties requested by his or her supervisor or the management of the company.

Job Type:

Full-time Pay:

$80,000.00 - $110,000.00 per year

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Health savings account Life insurance Paid time off Vision insurance Ability to

Relocate:

Milpitas, CA 95035: Relocate before starting work (Required)

Work Location:

In person