Scientist III, Quality Control (Middletown, VA)
Core
Ensuring reliable and compliant manufacturing and QC processes for high-quality clinical diagnostic products to support patient care globally.
Role type
Senior IC quality control scientist (clinical diagnostics)
Builds
Clinical diagnostic products
Domain
Life sciences / Clinical diagnostics / Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
HPLC operation, GC operation, root cause analysis, OOS investigation, cGMP compliance, ISO 13485 knowledge, stability testing, process validation, technical writing
Preferred skills
CAPA implementation, audit support, instrumentation troubleshooting, process improvement, mentoring
Technologies
HPLC, GC
Responsibilities
Perform routine and non-routine analytical testing using HPLC and GC; Lead investigations related to deviations, OOS results, and nonconformances; Support stability testing programs and trend analytical data; Support process validation, assay qualification, and technology transfer; Review technical documentation including protocols, reports, SOPs, and change controls; Mentor junior scientists and provide technical expertise.
Seniority
Senior, hands-on IC