Manager, Quality Assurance

6 days ago

🏢 In-office - Bay Area

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Logo of Codexis, Inc.

Codexis, Inc.

We deliver exquisite enzymes for the betterment of human health.

Biocatalysis • Directed Evolution • Enzyme Optimization • Biocatalysts • Enzyme Engineering

51 - 200

Description

• Quality oversight of the ECO Synthesis™ program and Pharma Manufacturing business including review of CMO deviations, change controls and disposition documentation supporting batch release. • Collaborates with cross functional departments to achieve the objectives of the company. Work directly with internal and external operational groups to ensure that products meet quality standards, specifications, and requirements. • Manage and maintain internal quality systems and processes. • Provides direction and decision making for Quality systems records and reports such as deviations, lab investigations, change control, CAPAs, product complaints, SOPs, and validation protocols/reports. • Develop and execute continuous improvement initiatives of QA processes and SOPs. • Manage and support internal, external, and customer quality audits. • Manage Codexis Quality System Metrics and reporting.

Requirements

• Ability to manage projects (direct and indirect) and variable workloads to timelines. • Attention to detail with accuracy and thoroughness in all aspects, including organizational skills. • Previous experience in oversight and approval of quality systems documentation.

Benefits

• 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!

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