Quality Assurance Specialist

3 weeks ago

Boston, Massachusetts, United States Arcaea Full time

Arcaea is a biology-first beauty company building a new ingredient toolset for the beauty and personal care industry. We are creating pioneering ingredients, products, and stories accessible uniquely through biology.

Arcaea is building a new ingredient toolset for the beauty and personal care industry - one rooted in biotechnology with the aim of delivering radical performance and unparalleled sustainability that will also present new opportunities for storytelling.

Arcaea is seeking an experienced Quality Assurance Specialist to join our team and play a critical role in developing our ingredient toolset for the beauty and personal care industry. As a member of the Arcaea team, you will be responsible for leading Arcaea's QA/QC efforts.

No candidate will meet every single desired qualification. If your experience looks a little different from what we've identified and you think you can bring value to the role, we'd love to learn more about you

Author, review and approve Standard Operating Procedures (SOPs), Quality Risk Assessments (QRAs), Quality Plans related to manufacturing operations, as needed. Contribute to generation of Annual Product Reviews for production, QC and supply chain
Develop a Quality program including the implementation of a Quality Management System
Oversee all QA/QC activities at Contract Manufacturing organizations (CMO) and Contract testing laboratories
Batch Record Review: Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standards
Compliance Monitoring: Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policies
Review and approval of deviations / non-conformances and lead the strategic discussion for out of specification investigations with respect to operations or validation/qualification related matters
Implement audit program and manage audits
Documentation: Maintain accurate and detailed documentation related to quality assurance activities
Create and/or review and enforce Quality Agreements with CMO partners
Develop and manage the QA/QC budgets
Ensure QC work (analytical and non-analytical) meets quality and timing expectations to support operations
Represent the company with government agencies, vendors, and customers
Support regulatory efforts for the company in all product lines
Communicate QA & QC goals and progress with executive management and external partners as needed
Provide strategic input to Product Development, Manufacturing, and Platform Development initiatives to align with quality plans and budgets
Manage 3rd party testing laboratories including sample logistics

BS/ in Biology, Microbiology, Chemistry, or equivalent experience
5+ years of experience in quality assurance
A working knowledge of 21 CFR 710 FDA regulations
Ability to communicate at all levels of the organization and apprise senior management of critical issues
Familiarity with Good Manufacturing Practices (GMP) and their application in the biotech sector
Familiarity with batch records and their significance in maintaining product quality
Attention to Detail: Strong attention to detail and commitment to maintaining high-quality standards
Startup experience preferred

We feel that it's important to point out the obvious here – there's a serious lack of diversity in both the scientific fields and beauty industry, and that needs to change. Our goal is to help drive that change. We are deeply committed to diversity, equality, and inclusion in all its practices, especially when it comes to growing our team. Our culture promotes inclusion and embraces how rewarding it is to work with people from all walks of life.
We're working with the powerful biological engineering platform at Ginkgo Bioworks, so we must remain mindful of the many ways our technology can – and will – impact people around the world. Ginkgo and Arcaea care about how this platform and the products created are used. Having a diverse team to build it gives us the best chance that it's something we'll be proud of as it continues to grow. Therefore, it's critical that we incorporate the diverse voices and visions of all those who play a role in the future of biology in every industry.
We are committed to diversity, equality, and inclusion in all its practices. It is the policy of Arcaea to provide equal employment opportunities to all employees and employment applicants.

Disclaimer: This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee.

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