The Advanced Regenerative Manufacturing Institute (ARMl)IBioFabUSA is a member-based non-profit organization founded to build the biofabrication industry and transform the future of healthcare. ARMI provides wrap-around commercialization services to companies seeking to bring life-saving regenerative technologies to patients, as well as to innovators seeking to commercialize enabling technologies that will grow the industry's impact.
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
Exceptional interpersonal, written and verbal communication skills
Experience working in a fast-paced, dynamic, collaborative team environment
High energy, commitment, initiative, and perseverance
Associate 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
By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.