Quality Control Support Specialist
Core
Senior technical expert building a new GMP-compliant Quality Control organization for animal health manufacturing, ensuring compliance, driving continuous improvement, and supporting operational excellence.
Role type
Senior IC Quality Control Subject Matter Expert (SME)
Builds
GMP-compliant animal health products and a new EU/FDA compliant manufacturing facility
Domain
Animal Health / Pharmaceutical Manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Quality Control laboratory operations and compliance)
Required skills
GMP compliance, Quality Management Systems (QMS), CAPA management, root cause analysis, laboratory equipment lifecycle management, validation and qualification, LIMS implementation, stability studies, change control, data analysis and trending
Preferred skills
Continuous improvement, digitalization, automation, project management, mentoring, technical writing
Technologies
LIMS, SAP, computerized laboratory systems, digital quality management platforms
Responsibilities
Act as SME for GMP compliance and quality systems; Lead complex investigations, deviations, and CAPA activities; Own and drive quality system processes; Review and approve GMP documentation; Ensure laboratory operations comply with regulatory requirements; Lead qualification and validation activities; Drive continuous improvement and efficiency projects; Provide expert support to cross-functional teams; Monitor laboratory data and performance metrics; Lead cross-functional projects and mentor colleagues.
Seniority
Senior, hands-on IC with leadership responsibilities