Quality Intern

Job Description

Job Description

This internship is funded through a grant program with specific eligibility requirements. In accordance with the grant terms, applicants must be currently enrolled students at Southern New Hampshire University. We encourage all eligible students to apply.

Overview

The Advanced Regenerative Manufacturing Institute (ARMI) is a member-based, non-profit organization whose mission is to advance the bioeconomy of the United States. As part of its technical efforts, ARMI is applying advanced automation and analytical techniques to develop scalable, consistent, and cost-effective manufacturing processes for cells, tissues, and organs.

The Impact That You Will Make

Quality Interns are instrumental to supporting PD-through-GMP operations. Taking a phase-appropriate approach, Quality Interns at ARMI help to maintain the facility, materials, and processes within a state of continuous control.

The Quality Intern supports both Quality Assurance and Quality Control teams, with a primary focus on documentation. This is an excellent opportunity for a student to make an impact while learning about the cutting-edge fields of tissue engineering and automation.

Your Role

• 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.
• Support routine lab cleaning and material inventory.
• Assist with the creation and revision of SOPs, test methods, and data forms.
• Document all operations according to GDP.

Your Skills and Experiences

• Exceptional interpersonal, written and verbal communication skills
• Experience working in a fast-paced, dynamic, 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 GDP, GLP, and GMP principles
• Experience with electronic Quality Management Systems
• Knowledge of FDA regulations, especially 21 CFR Part 210, 211, 610
• Aseptic gowning experience within a controlled cleanroom environment
• 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

Hours Expected: 30 - 39 per week

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