Quality Assurance Associate
About The Position
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.
Requirements
- 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
Nice To Haves
- Knowledge of FDA GMP regulations is desired, especially 21 CFR Part 210, 211, and 600
Responsibilities
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
Associate degree
