QARA Intern

OUR TEAM: The Validation team includes engineers and scientists with a wide range of industry experience and backgrounds. We ensure Promega's systems and processes perform as intended and stay in full compliance with quality standards. Our team works closely with groups across the company to keep validated systems running efficiently and supporting reliable operations. We combine technical problem-solving with process discipline and value curiosity, collaboration, and continuous improvement. It's a great environment to learn how validation and quality assurance come together to support a dynamic biotech manufacturing organization.

YOUR ROLE: In this role, you'll support the Validation team in executing scheduled equipment and system qualifications as well as validation reviews. You'll help plan and run qualification activities, collect and analyze data for validation reviews, coordinate with cross-functional groups to schedule work, and maintain accurate documentation throughout each project. This internship provides hands-on experience with validation in a regulated manufacturing environment and insight into how engineering, quality, and operations intersect to maintain compliant, reliable systems. It's a great opportunity to apply your technical skills, learn from experienced mentors, and contribute to meaningful projects that support Promega's mission and daily operations.

JOB OBJECTIVE: The QARA Intern will support the Quality Assurance and Regulatory Affairs teams by assisting in various quality and regulatory tasks. This internship offers hands-on experience in maintaining compliance with regulatory standards, improving operational processes, and supporting overall quality initiatives. The intern will gain exposure to various activities within QA and RA, helping to ensure product, process, and documentation integrity.

**This is a paid internship, but there is no housing/moving stipend available.

CORE DUTIES:

1. Collaborate with cross-functional teams to support quality initiatives and regulatory projects.

2. Investigate and identify performance and process issues, proposing timely recommendations for resolution to management.

3. Assist in documentation and logistical tasks related to quality activities, ensuring accurate record-keeping and adherence to protocols.

4. Assist in audits by helping to identify and retrieve necessary documents or records in a timely manner.

5. Provide general administrative support to the QA&RA (Quality Assurance & Regulatory Affairs) team as assigned.

6. Demonstrates inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.

7. Embracing and being open to incorporating Promega's 6 Emotional & Social Intelligence (ESI) core principles in daily work.

8. Understands and complies with ethical, legal and regulatory requirements applicable to our business.

KEY QUALIFICATIONS:

1. Currently pursuing a degree in a science or engineering discipline (e.g., Biology, Chemistry, Biomedical Engineering, Mechanical Engineering, etc.).

2. Strong analytical and problem-solving skills with the ability to identify issues and propose effective solutions.

3. Excellent organizational skills with attention to detail and accuracy in documentation.

4. Demonstrated proficiency in digital tools and technology, including Microsoft applications and mobile platforms, with the ability to adapt and leverage emerging technologies, such as artificial intelligence, to improve efficiency, automation, and collaboration.

5. Effective communication skills, both written and verbal, with the ability to collaborate with cross-functional teams.

PREFERRED QUALIFICATIONS:

1. Prior experience or coursework related to quality assurance or regulatory affairs in a manufacturing environment.

2. Familiarity with regulatory standards (e.g., FDA, ISO) and their application in a manufacturing setting.

3. Experience with laboratory equipment and validation software tools.

PHYSICAL DEMANDS:

1. Ability to remain stationary for extended periods.

2. Ability to move and position oneself to access equipment and documents as required.

3. Ability to transport items weighing up to 20 pounds between locations.

4. Ability to use a computer and related software for long periods.

At Promega, we value diversity and strive to create an inclusive workplace. We are proud to be an Equal Opportunity Employer, making employment decisions without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, disability, or any other protected class.