Quality Intern

Overview

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, non-profit organization dedicated to advancing the bioeconomy of the United States. ARMI applies advanced automation and analytical techniques to develop scalable, consistent, and cost-effective manufacturing processes for cells, tissues, and organs.

Responsibilities

• Support electronic and paper-based Quality System documentation management efforts, including scanning, filing, and organization of subsystems.
• Review data and executed forms generated across the manufacturing facility and QC lab for compliance with ALCOA++ principles.
• Support internal Quality auditing operations.
• Assist with QC microbiology activities such as environmental monitoring, media incubation, colony counting, and the identification of microbial recoveries.
• Assist with routine lab cleaning and material inventory.
• Aid in the creation and revision of Standard Operating Procedures (SOPs), test methods, and data forms.
• Document all operations according to Good Manufacturing Practices (GMP).

Requirements

• Currently enrolled students at Southern New Hampshire University.
• Exceptional interpersonal, written, and verbal communication skills.
• Experience working in a fast-paced, dynamic, and collaborative team environment.
• High energy, commitment, initiative, and perseverance.
• Progress toward an Associate's or Bachelor's degree in a biological science discipline.
• Familiarity with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and FDA regulations, particularly 21 CFR Part 210.
• Aseptic gowning experience within a controlled cleanroom environment.
• Strong verbal and written technical communication skills.
• Competency with Microsoft Office suite, especially Microsoft Word and Excel.
• A collaborative attitude, sense of curiosity, and eagerness to manifest positive change.

Qualifications

• Progress toward an Associate's or Bachelor's degree in a biological science discipline.
• Familiarity with FDA regulations, especially 21 CFR Part 210, 211, and 610.
• Aseptic gowning experience within a controlled cleanroom environment.
• Strong verbal and written technical communication skills.
• Competency with Microsoft Office suite, especially Microsoft Word and Excel.
• A collaborative attitude, sense of curiosity, and eagerness to manifest positive change.