ADVANCED REGENERATIVE MANUFACTURING INSTITUTE
Quality Assurance Associate
ADVANCED REGENERATIVE MANUFACTURING INSTITUTE, Manchester, New Hampshire, us, 03103
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 SystemReview data and executed forms for GDP complianceManage document control and issuanceDraft SOPs and coordinate their review and approvalFacilitate training programTrack Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)Identify potential continuous improvements to the Quality SystemManage record retention for data and Quality System filesProvide formatting review to documentation as needed for consistency of style, voice, and appearanceEnsure site readiness for audits and regulatory inspectionsYour Skills and Experiences
Associate's or Bachelor's degree with 2+ years of experience in GMP biotech/pharmaceutical Quality roleDemonstrated experience with GDP to ensure operations uphold product quality and complianceStrong verbal and written technical communication skillsExperience with electronic Quality Management SystemsCompetency with MS Office suite, especially formatting within MS Word and ExcelKnowledge of FDA GMP regulations is desired, especially 21 CFR Part 210, 211, and 600Collaborative attitude, sense of curiosity, and eagerness to impact positive change
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 SystemReview data and executed forms for GDP complianceManage document control and issuanceDraft SOPs and coordinate their review and approvalFacilitate training programTrack Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)Identify potential continuous improvements to the Quality SystemManage record retention for data and Quality System filesProvide formatting review to documentation as needed for consistency of style, voice, and appearanceEnsure site readiness for audits and regulatory inspectionsYour Skills and Experiences
Associate's or Bachelor's degree with 2+ years of experience in GMP biotech/pharmaceutical Quality roleDemonstrated experience with GDP to ensure operations uphold product quality and complianceStrong verbal and written technical communication skillsExperience with electronic Quality Management SystemsCompetency with MS Office suite, especially formatting within MS Word and ExcelKnowledge of FDA GMP regulations is desired, especially 21 CFR Part 210, 211, and 600Collaborative attitude, sense of curiosity, and eagerness to impact positive change