Quality Assurance Specialist
1 month ago
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.
Key Responsibilities:- Develop and implement Quality Management Systems to ensure compliance with regulatory requirements and company policies.
- Oversee all QA/QC activities at Contract Manufacturing organizations (CMO) and Contract testing laboratories.
- Review and analyze batch records for adherence to Good Manufacturing Practices (GMP) and internal quality standards.
- Collaborate with cross-functional teams to monitor compliance with regulatory requirements and company policies.
- Implement audit programs and manage audits to ensure quality and regulatory compliance.
- Maintain accurate and detailed documentation related to quality assurance activities.
- Develop and manage QA/QC budgets and ensure QC work meets quality and timing expectations.
- Represent the company with government agencies, vendors, and customers.
- Support regulatory efforts for the company in all product lines.
- 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.
Competitive hourly rate of $38-$48 USD.
We are committed to diversity, equality, and inclusion in all our practices.
Arcaea participates in E-verify to determine employment eligibility.
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