QC Specialist I

Department: 64 - Quality Control

Employment Type: Full Time

Location: Redwood City, CA

Reporting To: Roy Yeung

Compensation: $120,000 - $150,000 / year

Description

Codexis, a biotechnology company based in Redwood City, CA, is looking to hire a Quality Control Specialist I.

Codexis is a leading enzyme engineering company leveraging its proprietary CodeEvolver® technology platform to discover, develop and enhance novel, high-performance enzymes and other classes of proteins. Codexis enzymes solve for real-world challenges associated with small molecule pharmaceuticals manufacturing and nucleic acid synthesis. The Company is currently developing its proprietary ECO Synthesis™ platform to enable the scaled manufacture of RNAi therapeutics through an enzymatic route. Codexis enzymes can drive improvements, such as higher yields, reduced energy usage and waste generation, improve efficiency in manufacturing and greater sensitivity in genomic and diagnostic applications. 

To meet the goals we’ve set for ourselves, we look for individuals who are driven, eager to grow and ready to embrace meaningful challenges. We empower employees to be authentic, ambitious, agile and have the courage to take action where they can make a positive impact.
Come join us on this journey to transform the enzyme engineering landscape for the betterment of human health.

About the Opportunity:
The Quality Control Specialist I role leads critical quality control functions by performing and overseeing analytical testing, method validation, and external contractor coordination to ensure product integrity and regulatory compliance. They drive operational excellence through SOP development, 5S implementation, and daily lab maintenance that supports a well-organized and efficient QC environment. By managing investigations, qualifications, and documentation, the role significantly contributes to risk mitigation and continuous improvement across the organization and quality team.

Key Responsibilities

In this role you will be responsible for:
• Perform analytical testing of in-process samples, finished products, and stability studies in accordance with established protocols.
• Serve as validation lead and subject matter expert to support analytical method validation activities. 
• Facilitate and oversee analytical testing performed by external contractors to ensure compliance and timely execution.
• Contribute to the implementation and ongoing maintenance of 5S principles within the QC laboratory to promote efficiency and organization.
• Create or update QC SOPs, protocols, and reports—including stability protocols, qualification documents, and summary reports.
• Perform daily laboratory tasks such as data review, laboratory maintenance, sample receipt and disposal, and chart recorder upkeep.
• Support laboratory investigations including OOT/OOS events, deviations, change controls, and CAPAs.
• Perform qualification of controls, reference materials, and critical reagents. 

Skills, Knowledge & Expertise

• BS in Analytical Chemistry, Biochemistry or Biological Sciences or equivalent with 8+ years of industrial Quality Control experience.
• Working knowledge of cGMP/ICH/ISO guidelines related to lab processes and GDP.
• Working experience with enzymatic assays, ELISA, HPLC, LC/MS, GC, Karl Fischer, UV-Vis, qPCR, CE-SDS and electrophoresis.
• Strong interpersonal and communication skills, both verbal and written, with a proven ability to work cross-functionally and present technical information clearly.
• Experienced in authoring and reviewing validation protocols and technical reports to support method validation. 
• Meticulous approach to documentation, data integrity, and procedural accuracy.
• Ability to multitask and deliver high-quality results under tight timelines, while maintaining compliance and thorough documentation.

Job Benefits

What can Codexis offer you?
• Medical, Dental and Vision Insurance 
• Basic Life, AD&D, Short- and Long-Term Disability Insurance 
• 401k with Company Match up to 4% 
• Company Equity 
• Generous Paid Time Off including 18 Company Holidays (with a summer and winter shutdown), Vacation, and Wellness Time 
• Annual Lifestyle Account for reimbursement of fitness programs, equipment and more 
• Employee Stock Purchase Program (ESPP) 
• Flexible Spending Accounts (Commuter/Parking, Dependent Care & Healthcare)
• Student Debt Program (Company Contribution to Loans)
• Mental Health Wellness Program
• Subsidized onsite lunch program
• Onsite Gym Facilities
• Paid Parental Leave
• And More!