Quality Assurance Specialist/Senior Specialist

OverviewThe 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 MakeQuality Assurance Specialists/Senior Specialists are critical to our success. In this role, you will support quality system initiatives, ensuring compliance to federal regulations and internal operating procedures at appropriate stages during the development and manufacture of complex biologic products. Reporting to the Director of Quality, you will contribute to establishing a world-class Quality department and uphold best practices that are appropriate for our programs. Your RoleBe a champion for continuous improvement and identify and implement solutions to enhance quality system effectivenessDevelop, review, and approve Quality System SOPsReview technical data in support of GLP/GMP operationsExecute and track Quality System Events (e.g., deviations, CAPAs, risk assessments, and change controls)Participate in root cause analysis investigations to identify, mitigate, and prevent nonconformancesDevelop engaging programs to effectively train ARMI personnelReview and approve master batch records for GMP Tissue Foundry processesOwn the document control and issuance processesPerform line clearances of manufacturing spaces Ensure site readiness for audits and regulatory inspectionsCollaborate with Tech Team, Program Management, and external stakeholders to facilitate technical transfer of incoming projects Your Skills and ExperiencesExceptional interpersonal, written and verbal communication skillsExperience working in a fast-paced, dynamic, collaborative team environmentHigh energy, commitment, initiative, and perseveranceBachelor of Science Degree in life sciences or engineering disciplineMinimum of 2+ years of direct work experience in GMP biotech/pharmaceutical Quality Knowledge of FDA regulations, especially 21 CFR Part 210 and 211Exceptional written and verbal communication skillsComfortable executing multiple quality system efforts in a fast-paced, dynamic, and highly collaborative team environmentProficient with Microsoft software products, especially formatting within MS WordCollaborative attitude, sense of curiosity, and eagerness to impact positive change Experience in the CDMO business model is desiredBy applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.