Quality Assurance Engineer II (4062) at Amyris, Inc. in Emeryville, California

Job Description:

Amyris, Inc.

Amyris is seeking a highly motivated and collaborative Quality Assurance Engineer II to play a key role in developing and implementing quality systems across our global research and manufacturing sites. This position offers an exciting opportunity to contribute to the production of high-quality products, ensuring they meet specifications and align with customer requirements.
In this role, you will be responsible for overseeing quality systems, including the monitoring of intermediate and final product specifications, tracking quality records, investigating and resolving non-conformances, and supporting new product development teams. You will work cross-functionally with a variety of teams, ensuring the integration of Quality Management Systems (QMS) across suppliers, manufacturing, R&D, and product development functions.
The ideal candidate will have strong experience in Quality Assurance within a fast-paced environment, ideally in highly regulated industries such as pharmaceuticals, biotechnology, or food manufacturing. You should have the ability to lead cross-functional initiatives, investigate process improvements, and apply best practices to deliver consistent, reliable results.

Responsabilities

• Develop and implement quality systems across research and manufacturing sites, ensuring alignment with customer requirements and industry best practices.
• Monitor product specifications and testing to ensure delivery of high-quality products that meet customer standards.
• Analyze data to make informed recommendations for continuous improvement in quality processes.
• Manage the QMS for materials, manufacturing, packaging operations, sanitation, test and inspection, and final product disposition.
• Collaborate with Quality Control, Logistics, R&D, and Product Management teams to ensure comprehensive documentation, specifications, and methodologies for manufacturing processes.
• Lead investigations into non-conformances and work with internal and external teams to identify corrective actions.
• Maintain accurate quality tracking records, including certificates of analysis, control charts, calibration records, etc.
• Review and approve new customer specifications and manufacturing batch records.
• Develop and implement stability protocols, conducting stability setup and generating reports for new and existing products.
• Support product disposition and ensure that product releases align with business development goals.
• Conduct internal inspections and external vendor audits to ensure compliance with regulatory standards and industry best practices.
• Represent Quality Assurance in cross-functional meetings, driving alignment across teams and departments.

Basic Qualifications

• Bachelor's degree in Chemistry, Engineering, or a related field with a minimum of 5 years of relevant experience, or a Master's degree in a related field with at least 3 year of relevant experience.
• 3+ years of Quality Assurance experience in chemical, continuous flow, or food manufacturing.

Preferred Qualifications

• Experience in pharmaceutical or biotechnology industries, or other highly regulated environments.
• Proven project management skills, with the ability to drive initiatives and collaborate across teams.
• Strong organizational, time-management, and multi-tasking abilities.
• Excellent communication and interpersonal skills, with the ability to work independently and as part of a cross-functional team.
• Proficiency in both written and oral presentations.
• Ability to travel up to 15% of the time.
• Experience with ISO 9000 corporate qualification and compliance.

Amyris is committed to fair and equitable compensation practices.  The pay range for this role is $105,500 to $150,500. Salary offers are made based on internal equity and market analysis, and will vary based on the candidate's skills, depth of experience and specific work location. Amyris is committed to providing a diverse array of inclusive benefits and perks to support employees and their families' wellbeing including access to robust healthcare, mental wellness benefits, family leave, discounted fitness memberships, education reimbursement, generous product discounts, flexible paid time off, 17 paid holidays, 10 paid sick days, and additional paid time off including 3 volunteer days, and bereavement.

PI259435420

Apply Now