Descripción
Our Schachen serves as a magnetic force that attracts, recognizes, and integrates people from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but that the site belongs to and is shaped by them. Our Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. The site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement. The Compliance Excellence Specialist (P2) supports operational compliance and quality system activities for GMP biologics manufacturing at our Schachen. This role contributes to right-first-time execution, operational continuity, and inspection readiness by supporting investigations, documentation, change controls, risk records, and continuous improvement activities within assigned areas. Working with direction and guidance, the role applies developing GMP and quality system knowledge to solve straightforward compliance topics, support timely closure of quality records, and contribute to cross-functional alignment with Manufacturing, Quality, Engineering, and MSAT. The position focuses on reliable execution, learning through hands-on assignments, and building the experience required to independently manage broader compliance topics over time. Responsibilities: Compliance Support & Issue Resolution • Support the resolution of GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope. • Apply standard procedures and GMP expectations to assess issues and propose recommended actions with guidance. • Support root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes. • Escalate risks, delays, or unclear situations in a timely and structured manner. Change & Risk Management • Support GMP product-related change controls and ri