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Quality Assurance Engineer II (4062)

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.

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Average salary estimate

$128000 / YEARLY (est.)
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$105500K
$150500K

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What You Should Know About Quality Assurance Engineer II (4062), Amyris

Amyris is on the lookout for a dynamic Quality Assurance Engineer II to join their team in Emeryville, CA! If you're passionate about creating high-quality products and ensuring they meet specifications, this position is for you. In this role, you’ll be at the forefront of developing and implementing quality systems that span across our global research and manufacturing sites. You’ll monitor product specifications, track quality records, and play a vital role in investigating and resolving non-conformances. As a collaborative team player, you’ll work alongside cross-functional teams, integrating Quality Management Systems across suppliers, manufacturing, R&D, and product development functions. With a strong background in Quality Assurance, particularly in fast-paced, regulated industries like pharmaceuticals or biotechnology, you'll be the leader driving initiatives for process improvement and applying best practices. Your work will ensure our products not only meet but exceed customer requirements. If you're ready to make an impact and drive quality assurance at Amyris, we can't wait to hear from you!

Frequently Asked Questions (FAQs) for Quality Assurance Engineer II (4062) Role at Amyris
What are the main responsibilities of a Quality Assurance Engineer II at Amyris?

As a Quality Assurance Engineer II at Amyris, you will develop and implement quality systems across research and manufacturing sites. Your responsibilities will include monitoring product specifications, managing documents relating to quality, leading investigations into non-conformances, and collaborating with various teams to ensure comprehensive quality practices are maintained.

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What qualifications are needed to apply for the Quality Assurance Engineer II position at Amyris?

To qualify for the Quality Assurance Engineer II position at Amyris, candidates should have a Bachelor’s degree in Chemistry, Engineering, or a related field with at least 5 years of relevant experience, or a Master's degree with a minimum of 3 years of experience. Familiarity with regulated environments such as pharmaceuticals or biotechnology is highly preferred.

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How does Amyris ensure product quality in its manufacturing processes?

Amyris ensures product quality by integrating robust Quality Management Systems (QMS) across various teams including Quality Control, R&D, and Manufacturing. This includes monitoring product specifications, conducting internal inspections, maintaining accurate quality records, and leading investigations to resolve non-conformances.

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What skills are essential for success as a Quality Assurance Engineer II at Amyris?

Essential skills for success as a Quality Assurance Engineer II at Amyris include excellent communication, project management abilities, strong organizational skills, and proficiency in conducting data analysis for continuous improvement initiatives. Candidates should also be able to work independently and collaboratively within a team.

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What is the salary range for a Quality Assurance Engineer II at Amyris?

The pay range for a Quality Assurance Engineer II at Amyris is between $105,500 and $150,500. Salary offers are based on internal equity, market analysis, skills, experience, and specific work location.

Join Rise to see the full answer
Common Interview Questions for Quality Assurance Engineer II (4062)
Can you explain your experience in Quality Assurance within regulated industries?

In answering this question, highlight specific experiences you’ve had in Quality Assurance roles, particularly in regulated industries like pharmaceuticals or biotechnology. Discuss your familiarity with quality systems, compliance standards, and how you've successfully navigated challenges in ensuring product safety and quality.

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How do you approach monitoring product specifications?

Discuss a systematic approach you utilize to monitor product specifications, such as implementing robust quality checks at various production stages and using statistical methods for analysis. Provide examples of how this has led to improvements in product quality.

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Describe a challenge you faced in QA and how you resolved it.

Use the STAR (Situation, Task, Action, Result) method to frame your answer. Detail the challenge, your role, the steps you took to address it, and the positive outcome that resulted from your actions.

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How do you stay current with industry regulations and best practices?

Mention specific resources such as industry publications, webinars, and professional organizations that you follow to stay updated. Emphasize your commitment to continuous learning and how you implement new knowledge in your work.

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What tools and technologies are you familiar with for quality management?

List tools you have experience with, such as Quality Management Systems software, data analysis tools, or laboratory information management systems. Explain how these tools enhance quality assurance processes and improve efficiency.

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How do you ensure effective communication across cross-functional teams?

Emphasize the importance of clear communication and outline strategies you use to maintain effective dialogue between teams, such as regular updates, collaborative meetings, or using shared documentation tools to keep everyone informed.

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What strategies do you use to investigate non-conformances?

Discuss your methodical approach to investigating non-conformances, including root cause analysis and documentation. Highlight your experience in collaborating with various teams to implement corrective actions effectively.

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How do you prioritize tasks in a fast-paced environment?

Explain your approach to prioritization, focusing on how you assess task urgency and importance. Provide examples of how prioritizing effectively has impacted project outcomes positively.

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Explain your experience with ISO 9000 compliance.

Detail your understanding of ISO 9000 standards, experiences you’ve had in achieving compliance, and how these standards affect quality management processes. Use specific examples to illustrate your point.

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How do you ensure continuous improvement in quality processes?

Discuss the methodologies you use for continuous improvement, such as Six Sigma or Kaizen. Emphasize your experience in using data-driven decision-making to implement improvements that enhance product quality and operational efficiency.

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January 8, 2025

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