QC Project Leader 80-100% (m/w/d)
Core
Lead QC projects and manage chemical/physical testing of raw materials, in-process samples, and finished products to ensure GMP compliance and support product release.
Role type
Senior QC Project Leader / Manufacturing Science and Technology Expert
Builds
Production quality data and validated analytical methods for drug products
Domain
Life Sciences / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Project management, analytical chemistry (HPLC, GC, UV/Vis, KF, FTIR), method development and validation, GMP/cGMP compliance, root cause analysis, CAPA implementation, technical documentation, cross-functional collaboration, team leadership
Preferred skills
Change control management, OOS/OOT/OOE investigation, external contract lab coordination, audit support, continuous improvement initiatives
Technologies
HPLC, GC, UV/Vis, KF, FTIR
Responsibilities
Manage QC projects from initiation to completion; perform and oversee chemical/physical testing; develop and validate chromatographic methods; troubleshoot analytical instrumentation; ensure GMP compliance; manage change controls and investigations; author technical documents and SOPs; act as QC point of contact for customer projects; coordinate with external contract laboratories; provide technical coaching to junior staff; participate in audits.
Seniority
Senior, hands-on IC with leadership responsibilities
