Quality Control Associate
About The Position
The Advanced Regenerative Manufacturing Institute (ARMI)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. 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.
Requirements
- 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
Nice To Haves
- 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
Responsibilities
- 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
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
