Quality Assurance Associate
: Job Details :

ARMI's mission is to develop a highly diverse, competitive, capable, and innovative domestic cell, tissue, and organ-manufacturing ecosystem that will fundamentally change healthcare for chronic disease and traumatic injury and to establish the trained and ready workforce essential for that ecosystem, centered in Manchester, NH. Our goal is to improve lives by cost-effectively restoring or replacing the function of damaged cells, tissues, and organs for patients and warfighters. The Impact That You Will Make Quality Assurance Associates are instrumental in ensuring PD-through-GMP process alignment, traceability, and regulatory compliance. Taking a phase-appropriate approach to quality system implementation, Quality Assurance Associates at ARMI help to translate regulatory expectations into actionable, on-the-floor controls maintained within the Quality Management System. The Quality Assurance Associate reports to the Director of RA/QA, and works closely with Quality Assurance Specialists, Process Development, DTCC, Program Management, Operations Support, and Regulatory. This is an excellent opportunity for a Quality professional to shape new facilities while learning about the cutting-edge fields of tissue engineering and automation. Your Role

• Assist with onboarding and oversight of an electronic Quality Management System
• Review data and executed forms for GDP compliance
• Manage document control and issuance
• Draft SOPs and coordinate their review and approval
• Facilitate training program
• Track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)
• Identify potential continuous improvements to the Quality System
• Manage record retention for data and Quality System files
• Provide formatting review to documentation as needed for consistency of style, voice, and appearance
• Ensure site readiness for audits and regulatory inspections

Your Skills and Experiences

• Associate's or Bachelor's degree with 2+ years of experience in GMP biotech/pharmaceutical Quality role
• Demonstrated experience with GDP to ensure operations uphold product quality and compliance
• Strong verbal and written technical communication skills
• Experience with electronic Quality Management Systems
• Competency with MS Office suite, especially formatting within MS Word and Excel
• Knowledge of FDA GMP regulations is desired, especially 21 CFR Part 210, 211, and 600
• Collaborative attitude, sense of curiosity, and eagerness to impact positive change