Quality Control Operations Specialist
Core
Provide on-the-floor technical support to QC analysts and lab operations teams, troubleshooting instruments and workflows in a highly automated drug substance manufacturing facility.
Role type
QC Lab Operations Specialist
Builds
Drug substance manufacturing operations
Domain
Life Sciences / Pharmaceutical Manufacturing
Required skills
Laboratory instrumentation troubleshooting, GMP compliance, Root cause analysis, Protocol execution, SOP drafting, Data integrity principles
Preferred skills
HPLC/GC experience, Validation protocol execution, Vendor coordination
Technologies
HPLC, GC, LIMS, CDS, Networked data acquisition systems
Responsibilities
Troubleshoot hardware, firmware, and software issues on chromatography systems and other QC instrumentation; Support analysts during first executions of new methods and instruments; Execute IQ/OQ/PQ, method verification, and engineering run protocols; Participate in laboratory investigations (OOS, OOT) and deviations by gathering data and reviewing audit trails; Draft or revise SOPs and work instructions; Track trends in instrument failures and invalid assays; Coordinate service visits and preventive maintenance with vendors.
Seniority
Mid-level IC (2+ years experience required for this level)
