FSP – QC Specialist – Raw Materials
Core
Develop, author, review, and implement GMP-compliant raw material specifications for biologics manufacturing to support facility startup and qualification.
Role type
QC Specialist (Raw Materials)
Builds
Raw material specifications, qualification reports, and master data for biologics manufacturing
Domain
Biologics manufacturing / Pharmaceutical Quality Control
Required skills
GMP documentation, biologics raw materials, specification development, supplier qualification, regulatory compliance (ICH/USP), electronic quality systems, technical writing
Preferred skills
Laboratory startup/commissioning, equipment qualification, compendial requirements (USP/EP/JP), supplier audits
Technologies
ERP, LIMS, electronic quality management systems
Responsibilities
Author raw material specifications for cell culture media, buffers, resins, and packaging; Support supplier onboarding and material lifecycle management; Collaborate on facility startup and lab commissioning; Ensure compliance with GMP and regulatory expectations
Seniority
Mid-Senior, hands-on IC