Quality Assurance Specialist

1 month ago


Boston, Massachusetts, United States Arcaea Full time
Job Title: Quality Assurance Specialist

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.
Requirements:
  • 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.
What We Offer:

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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