Quality Assurance Specialist (Part-time) - Arcaea
Boston, MA
About the Job
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!
WHAT YOU WILL DO:
- 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
WHAT WE SEEK:
- 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 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.
Agency and Third Party Recruiter Notice: Agencies that submit a resume to Arcaea must have a current executed Arcaea Agency Agreement executed by the Director, People Operations. In addition Agencies may only submit candidates to positions for which they have been invited to do so by an Arcaea Recruiter. All resumes must be sent to the Arcaea Recruiter under these terms or they will not be considered.
If you have a disability under the Americans with Disabilities Act or similar law, or you require religious accommodation, and you wish to discuss potential accommodations related to applying for employment at our company, please contact recruiting@arcaea.com.
Arcaea participates in E-verify to determine employment eligibility.
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.
