Simtra BioPharma Solutions (Simtra) is a world-class Contract Development Manufacturing Organization, partnering with pharmaceutical and biotech companies to bring their sterile injectable products to market. With facilities in Bloomington, Indiana, US and Halle/Westfalen, Germany, we offer a wide range of delivery systems including pre-filled syringes, liquid/lyophilized vials, diluents for reconstitution, powder-filled vials and sterile crystallization.

Our product types include biologics and small molecules, cytotoxics, highly potent compounds, diluents for reconstitution and vaccines – which are all directly injected into patients worldwide. As such, there is a strong emphasis on quality and continuous improvement at Simtra. We hold ourselves to the highest quality and regulatory standards.

While our primary focus is cGMP manufacturing, we offer many support services including formulation and development, lyophilization optimization, global regulatory support and secondary packaging. Our teams are driven to help clients scale, innovate and bring life-changing medicines to patients worldwide.

Why join Team Simtra? Because we:

Make it HAPPEN – We bring a growth mindset to every opportunity, developing new skillsets and exceeding our expectations and those of our customers.

Make it TOGETHER – We work as one, respecting each voice and tapping into our unique strengths across teams—so we can solve problems in new ways.

Make it RIGHT – We hold ourselves to a high standard of excellence, fulfilling our commitments to the customer, their patients, and our team members.

Make it COUNT – We take pride in our day-to-day work, knowing the impact we make – taking on challenges big and small to improve patient health.

The Role:
Simtra is seeking highly motivated undergraduate and graduate students for our Summer Internship Program. We look for diverse students with inquisitive minds and the desire to challenge themselves. Our interns work closely with industry professionals and learn quickly how to problem solve on real-world projects that contribute to clinical research and manufacturing processes. In addition to on-the-job experience, we offer learning sessions with top leadership, site visits to local projects and social events.

The Opportunity:
The Quality Assurance department plays a key role in ensuring compliance, product integrity, and continuous improvement across pharmaceutical operations. As a Quality Associate Intern, you will support various quality system initiatives, including Corrective and Preventive Actions (CAPA), Product Quality Review (PQR), and other process improvement efforts. This internship offers exposure to quality data analysis, documentation practices, and cross-functional collaboration in a regulated environment.

Responsibilities/Projects:

• Assist in tracking and reviewing quality system records such as CAPAs and PQRs to ensure compliance with internal procedures and regulatory standards
• Support data analysis efforts to identify trends, root causes, and opportunities for improvement
• Participate in cross-functional meetings to understand quality processes and contribute to improvement initiatives
• Help maintain documentation and ensure records are complete, accurate, and audit-ready
• Collaborate with QA team members to streamline workflows and enhance system efficiency
• Prepare summary reports and presentations for internal stakeholders
• Gain exposure to electronic quality management systems (eQMS)

Required Qualifications:

• Currently pursuing a BS or MS degree in Life Sciences, Engineering, or a related field
• Strong analytical and organizational skills
• Excellent written and verbal communication
• Ability to work independently and in a team-oriented environment
• Familiarity with GMP, FDA regulations, or pharmaceutical industry practices is a plus.

Onsite Campus Amenities:

• Workout Facility
• Cafeteria
• Credit Union

Disclaimer

This job description is intended to provide the minimum knowledge, skills and abilities necessary to perform the job. It may not be inclusive of all the duties and responsibilities of the job. Simtra reserves the right to make modifications based on business requirements.

Equal Employment Opportunity

Simtra is proud to be an equal opportunity employer. Simtra evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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