Regenerative Manufacturing Quality Assurance Specialist
5 days ago
We are seeking a highly skilled Regenerative Manufacturing Quality Assurance Specialist to join our team at the Advanced Regenerative Manufacturing Institute Inc. in Manchester, NH.
About Us
The Advanced Regenerative Manufacturing Institute Inc. is dedicated to developing a diverse and competitive manufacturing ecosystem for cell, tissue, and organ production. Our mission is to revolutionize healthcare for chronic diseases and traumatic injuries by restoring or replacing damaged cells, tissues, and organs.
ResponsibilitiesQuality Assurance Associate Role
- GDP Compliance Expertise: Assist with onboarding and oversight of an electronic Quality Management System to ensure operations uphold product quality and compliance.
- Document Control Specialist: Manage document control and issuance, draft SOPs, and coordinate their review and approval.
- Training Program Facilitator: Develop and facilitate training programs to ensure site readiness for audits and regulatory inspections.
- Record Retention Manager: Oversee record retention for data and Quality System files.
- Compliance Consultant: Provide expertise on FDA GMP regulations, especially 21 CFR Part 210, 211, and 600.
- Collaboration and Communication: Work closely with Quality Assurance Specialists, Process Development, DTCC, Program Management, Operations Support, and Regulatory teams.
Your Skills and Qualifications
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