Analyst, Quality Control

Yowei Therapeutics; Milpitas (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

PTO 10 days

Company-paid holidays

Transportation/carpool reimbursement

Job summary

Yowei Therapeutics is seeking a Quality Control Analyst to perform and review analytical testing supporting raw materials, in-process, release, and stability testing in a GMP-lab setting in Milpitas, CA. The role emphasizes data integrity, method troubleshooting, and collaboration with cross-functional teams.

The candidate will lead investigations, support CAPAs, and help maintain compliance with regulated laboratory practices, documenting results and preparing training materials.

Qualifications

• 5–7 years of QC analytical experience in GMP-regulated labs.
• Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices.
• Hands-on experience with chromatographic and analytical instrumentation, data systems, and method troubleshooting.

Responsibilities

• Perform and document routine and complex analytical testing per approved methods, specifications, SOPs, protocols, and schedules.
• Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy and completeness.
• Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods.

Skills

QC analytical experience

cGMP knowledge

Data integrity

Documentation

Cross-functional communication

Education

Bachelor's degree in chemistry/biochemistry/pharmaceutical science

Tools

Chromatography instrumentation

Data systems

Job description

Yowei Therapeutics and Yowei Oncology are stealth-stage life-sciences companies working closely with CSBio to advance peptide-based clinical programs. Their work spans longevity and peptide therapeutics, clinical trials, evaluation of a 503A pharmacy model, personalized synthetic neoantigen peptide oncology programs, and supporting microbiology and laboratory capabilities. Together, they are building the clinical, pharmacy, data, laboratory, and operational infrastructure needed to responsibly translate peptide programs into patient-facing studies and services. Both companies expect to remain in stealth through Q1 2027.

CSBio is a peptide contract manufacturing founded in 1993. CSBio initial products were a complete line of automated synthesizers for manufacturing and process development, with a focus on cGMP production. In 1994, CSBio opened a custom peptide facility and began producing high quality compounds for research organizations and pharmaceutical companies worldwide. In 2004, CSBio opened a peptide production facility in Menlo Park, CA and in 2014, CSBio expanded production capability through the addition of a new, state of the art building dedicated to cGMP peptide production. In 2017, CSBio passed a FDA inspection and were recommended to be approved for commercial drug substance manufacturing. In 2023, additional cGMP clinical production capacity was added in Milpitas, CA.

We are seeking an experienced Quality Control Analyst to perform and review analytical testing supporting raw-material, in-process, release, stability, validation, and investigation activities. Core duties and responsibilities include the following:

Job Duties:

• Perform and document routine and complex analytical testing in accordance with approved methods, specifications, SOPs, protocols, and schedules.
• Review raw data, calculations, chromatograms, audit trails, worksheets, and results for accuracy, completeness, and compliance.
• Support or lead method transfer, verification, validation, troubleshooting, and lifecycle improvements for assigned methods.
• Execute raw-material, in-process, release, stability, cleaning, or investigation testing as assigned.
• Lead or support laboratory investigations, OOS/OOT assessments, deviations, CAPAs, and change controls.
• Operate, maintain, calibrate, and troubleshoot analytical instruments and laboratory systems; coordinate service when needed.
• Prepare and revise methods, SOPs, protocols, reports, specifications, forms, and training materials.
• Train and mentor analysts and provide technical guidance while preserving independent review requirements.
• Plan work against manufacturing and project priorities and communicate constraints or risks early.
• Support inspections, customer audits, data requests, and continuous-improvement initiatives.

• Bachelor's degree in chemistry, biochemistry, pharmaceutical science, or a related field.
• 5-7 years of QC analytical experience in pharmaceutical, biotechnology, API, or another GMP-regulated laboratory.
• Strong knowledge of cGMP, GDP, data integrity, OOS/OOT, deviations, CAPA, and controlled-document practices.
• Hands-on experience with relevant chromatographic and analytical instrumentation, data systems, and method troubleshooting.
• Strong documentation, technical writing, prioritization, and cross-functional communication skills.

• Medical, dental, and vision insurance (Kaiser HMO or BlueShield PPO. Employer pays 85% for Employee and 50% for Employee's family; Dental: Aetna Dental, Delta Dental, Guardian Dental, MetLife Dental. Vision: VSP and Aetna EyeMed)
• Basic life ($20,000 paid by company) and supplemental life insurance (optional supplemental).
• Disability insurance 50% standard employer paid.
• 401k 10% 1:1 match
• PTO policy. 10 days PTO
• Companywide paid holiday during: Week of July 4, Thanksgiving (2 days), Week of December 25
• Carpool, clean air vehicle, and cell phone reimbursement
• Employee rewards and recognition program
• Company organized social events
• Quarterly sponsored team building activities