Biologist / Quality Assurance Manager | Biologe (m/w/d)
Celonic Deutschland GmbH & Co. KG
Job Summary
As a Quality Assurance Manager (QA Shopfloor), you will play a critical role in ensuring GMP compliance directly within the cleanroom environments of active ingredient production. You will serve as the primary point of contact for production staff regarding acute quality issues and deviations, fostering a strong quality culture through direct coaching and training. Your day-to-day responsibilities include conducting GMP monitoring rounds, managing Corrective and Preventive Actions (CAPA), and overseeing change control processes. You will also be responsible for creating and approving essential documentation such as SOPs and reports while representing the QA function in both internal and client-facing projects. This position is ideal for professionals looking to work in a cutting-edge CDMO environment in Heidelberg, offering the chance to influence patient lives through innovative bioprocess technologies. The role is unique for its high level of visibility on the production floor and its integration into a multinational, family-owned organization with short communication paths.
Required Skills
Education
University degree in Biotechnology, Life Sciences, or a comparable field of study.
Experience
- 3 years of professional experience in Quality Assurance within a GMP environment
- Professional experience in biotechnological manufacturing within a CMO environment is advantageous
- Demonstrated knowledge in Quality Risk Management and current regulatory requirements
- Experience in creating, reviewing, and approving GMP documentation (SOPs, plans, reports)
Languages
Additional
- The role requires physical presence in cleanroom environments for shopfloor oversight and monitoring rounds. Located in Heidelberg, Germany.
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