Quality Control Associate

Job Description

Job Description

Overview

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 Control (QC) Associates are instrumental to supporting PD-through-GMP operations. Taking a phase-appropriate approach, QC Technicians at ARMI help to maintain the facility, materials, and processes within a state of continuous control.

The QC Associate reports to the Sr. QC Manager, and works closely with Quality Assurance, Process Development, Operations Support, and Program Management. This is an excellent opportunity for a technical professional to make an impact while learning about the cutting-edge fields of tissue engineering and automation.

Your Role

• Perform microbial and particulate sampling of ISO 7-9 cleanrooms
• Assist with the identification and trending of microbial recoveries
• Maintain ownership of QC equipment, ensuring units remain clean, calibrated, and validated, as necessary
• Support routine lab cleaning and material inventory
• Create and revise QC SOPs, test methods, and data forms
• Review data and executed forms generated by other QC team members
• Identify and communicate potential continuous improvements to the Quality System
• Support site readiness for audits and regulatory inspections
• Document all operations according to GDP

Your Skills and Experiences

• Associate's or Bachelor's degree in a biological science discipline; or, 1+ year of GMP bio-/pharmaceutical manufacturing industry experience
• Experience with environmental monitoring equipment (e.g., air samplers, media plates)
• Aseptic gowning experience within a controlled cleanroom environment
• Familiarity with GDP, GLP, and GMP principles
• Experience with electronic Quality Management Systems
• Knowledge of FDA GMP regulations, especially 21 CFR Part 210, 211, 610
• Strong verbal and written technical communication skills
• Competency with MS Office suite, especially MS Word and Excel
• Collaborative attitude, sense of curiosity, and eagerness to manifest positive change
• Exceptional interpersonal, written and verbal communication skills
• Experience working in a fast-paced, dynamic, collaborative team environment
• High energy, commitment, initiative, and perseverance

Work Environment

• Cleanroom laboratory environment with exposure to biologics, chemical reagents, and analytical instruments
• Occasional weekend coverage may be required
• Occasional overtime may be required to meet project deadlines

By applying, I understand that any offer of employment is contingent upon the successful completion of a background check, in accordance with applicable laws.