QC Technical Specialist II
Core
Perform testing and analysis of raw materials, in-process samples, and finished products using analytical techniques in a GMP environment to ensure product quality.
Role type
Senior IC QC Technical Specialist (Engineer/Scientist II)
Builds
Production quality data and validated lab systems
Domain
Pharmaceutical/Medical Devices Quality Control
Required skills
GMP regulations, analytical systems (LIMS, CDS, HPLC, GC, UV, IR), technical documentation, regulatory standards (ISO, FDA, USP, EP), lab equipment calibration, lab system qualification, continuous improvement, stakeholder collaboration
Preferred skills
Laboratory automation systems, pharmaceutical or medical devices industry experience, Chemistry/Biochemistry/Biology degree
Technologies
LIMS, CDS (Chromeleon/Empower), HPLC, GC, UV, IR, Microsoft Office
Responsibilities
Lead and deploy lab system projects as site SME, perform and support qualification of new equipment and lab systems, prepare technical documentation (protocols, reports, SOPs), ensure equipment maintenance and calibration compliance, support lab investigations, coach colleagues on lab systems, participate in practical process improvement, support site and regulatory audits
Seniority
Mid-level, hands-on IC
