Intern - Compliance & Quality Support (m|f|d)
- Full-time
- Department: Clinical Development EU
- Location: Bergisch Gladbach
- Functional Area: Qualitymanagement
- Company: Miltenyi Biomedicine GmbH
Company Description
Miltenyi Biomedicine is a biopharmaceutical company committed to advancing personalized cell and gene therapies. We are pioneering groundbreaking therapies for serious life-threatening diseases, and reshaping their accessibility for clinical professionals and patients worldwide with the aim to improve and extend patients' lives. We are currently focusing on difficult-to-treat hematological cancers using CAR-T and other technologies, while also exploring treatments for other diseases. Our lead candidate, a tandem CAR T-cell product, is currently undergoing pivotal clinical trials on a global scale.
Join our highly professional team in bringing new medicines to market and ensuring the safety of our pharmacological developments at all stages.
Job Description
The Intern supports the CTQC and ClinDevEU teams in administrative and documentation-related compliance activities. Under supervision, the role contributes to maintaining inspection- and audit-ready documentation, supporting training record management, tracking quality actions, and ensuring the accurate organization of quality-related records in accordance with internal procedures and applicable regulatory requirements.
Key Responsibilities
- Support the maintenance, organization, and archiving of quality and compliance documentation
- Assist with training documentation tracking and filing activities
- Perform administrative reviews and document pre-filing checks to ensure completeness and accuracy
- Support the tracking and follow-up of Corrective and Preventive Actions (CAPAs)
- Assist in maintaining trackers and logs related to quality and compliance activities
- Prepare meeting minutes and document action items from team meetings
- Support the coordination and follow-up of assigned administrative tasks
- Contribute to maintaining inspection- and audit-ready documentation
- Support sponsor oversight documentation activities as applicable
- Assist the team with general quality management and compliance-related administrative tasks
Qualifications
Required
- Currently enrolled in a Bachelor's or Master's degree program in Life Sciences, Pharmacy, Biotechnology, Biology, Biomedical Sciences, Healthcare Management, or a related field
- Strong interest in clinical research, quality management, and regulatory compliance
- Good organizational skills and attention to detail
- Proficient in Microsoft Office applications (Word, Excel, PowerPoint, Outlook)
- Good written and verbal communication skills in English
Preferred
- Initial knowledge of GCP (Good Clinical Practice), clinical research processes, or quality management systems
- Experience with document management systems or electronic filing systems
Competencies
- Structured and detail-oriented working style
- Strong organizational and documentation skills
- Ability to handle confidential information professionally
- Reliable and proactive approach to assigned tasks
- Ability to work effectively in a team environment
- Willingness to learn and develop in a regulated healthcare environment
Additional Information
Your workplace will be Bergisch Gladbach.
What we offer
- A modern workplace in Bergisch Gladbach with opportunity for some mobile work. Exciting opportunities in the development of technologies with a secure future.
- Cross-border intercultural cooperation and short communication channels
- A collegial corporate culture and flexible working hours enable time management on your own terms
- Personalized employee development program: specialist and personal training courses provided by our own Miltenyi University
We look forward to your application
If you want to work in an open, creative and supportive team, this is the place for you. We look forward to receiving your application along with your salary expectations and availability.
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