Quality Assurance Intern

Job Description

About the Job

Join Rocket Pharma and contribute to a future where DNA is no longer destiny. We are a fully integrated, late-stage biotechnology company relentlessly advancing gene therapies with curative potential for patients grappling with rare and life-threatening diseases. Our mission is powered by a team of creative, compassionate, and driven individuals dedicated to seeking gene therapy cures. Rocket Pharma places immense value on our people, fostering a collaborative environment where bold ideas thrive and every team member makes a meaningful impact. Our core values—trust, generosity toward patients, curiosity, and elevating science—guide every action we take.

Position Summary

Rocket Pharmaceuticals is excited to offer a paid 10-week summer internship designed for ambitious university students eager to gain hands-on experience within a dynamic and fast-paced biotechnology environment. This internship provides a unique opportunity to work alongside experienced professionals who are passionately dedicated to advancing transformative gene therapies.

We are actively seeking a motivated and enthusiastic candidate to join Rocket as an Intern within our Quality Assurance Department. This role will primarily focus on supporting the Document Control function and contributing to electronic Quality Management System (eQMS) enhancement efforts. A significant aspect of this internship will involve evaluating the use of technology, particularly commercially available AI tools, to improve the efficiency and effectiveness of our Quality systems, alongside providing general support for critical Quality Management Systems at Rocket.

Responsibilities

As a Quality Assurance Intern, your responsibilities will be diverse and impactful, offering a comprehensive learning experience:

Documentation Control:

• Evaluate the application of Artificial Intelligence (AI) in enhancing various Quality functions. This will include researching commercially available AI tools, assessing their potential utility, and preparing comprehensive reports with recommendations for their strategic integration into our Quality processes.
• Maintain, review, and meticulously update electronic Quality Management System (eQMS) documents, forms, and procedures, ensuring absolute compliance with relevant regulations (e.g., FDA, EMA) and industry standards (e.g., GxP).
• Gain a practical understanding of document control systems and actively contribute to their improvement, aligning with regulatory requirements and Rocket’s evolving business needs.
• Evaluate tools and strategies for migrating/importing electronic records from external vendors into Rocket’s internal electronic system (specifically, the commercially available eQMS, ZenQMS), focusing on data integrity and efficiency.
• Provide essential support for the systematic archival of physical documents within the document control room and the secure electronic archival of documents within our eQMS.

QMS Processes:

• Support critical QMS processes including CAPA (Corrective and Preventive Action), deviation management, change control, and risk management, contributing to the lifecycle management of these key quality events.
• Actively participate in QMS initiatives, gaining valuable insight into the comprehensive function of Quality Management Systems within a biotech company, and contributing to ongoing improvement efforts within the QMS function.
• Data Analysis & Metrics: Support the automation of data collection processes, generation of insightful reports, and creation of user-friendly dashboards to effectively track and visualize key quality performance indicators (KPIs), providing actionable insights.
• Project Support: Engage in various special projects, which may include supporting software validation activities, contributing to process improvement initiatives (e.g., mapping current and future state processes), or assisting in the digitization of paper-based systems.

Qualifications

We are looking for candidates who meet the following criteria:

• Currently a rising junior or senior undergraduate student pursuing a Bachelor’s degree in relevant fields such as: Biology / Biological Sciences, Biotechnology, Pharmacy / Pharmaceutical Sciences, Biochemistry / Chemistry, Engineering (Mechanical, Industrial, IT, Quality), or a closely related scientific or engineering discipline.
• Technical Skills: Proficiency in Microsoft Office Suite (especially Excel and Word) and a basic understanding of fundamental quality tools (e.g., Risk Assessment, FMEA, Deviation Investigation, CAPA, Root Cause Analysis).
• Soft Skills: Demonstrated strong analytical, communication (both written and verbal), and organizational skills, coupled with a high attention to detail, strong problem-solving abilities, and the capacity to work both independently and collaboratively within a team.
• Proficiency in using various Microsoft applications (such as MS Word, MS Excel, MS PowerPoint, MS Visio, Adobe Acrobat Professional) and SharePoint.

EEO Statement

A diverse workforce fosters innovation and strengthens Rocket’s business. We ensure equal opportunity without discrimination or harassment in the workplace on the basis of gender, race, color, religion, national origin, age, physical or mental disability, pregnancy, citizenship, status as a protected veteran, marital status, sexual orientation, gender identity and expression, genetic information, or any other characteristic protected by applicable local, state, and federal laws.