Quality Control Analyst II
Core
Execute and review routine in-process, drug substance, and stability test methods in a pharmaceutical manufacturing environment using laboratory instrumentation.
Role type
Quality Control Analyst II
Builds
Drug substance and stability test data for pharmaceutical products
Domain
Pharmaceutical manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Laboratory instrumentation operation, cGMP compliance, data integrity maintenance, SOP authoring and adherence, laboratory investigations, deviation management, CAPA initiation, change control management, environmental monitoring, reagent preparation, equipment calibration
Preferred skills
Life Sciences degree, regulated environment experience, cross-functional team collaboration, training new analysts
Technologies
LIMS, SoftmaxPro, Charles River Endoscan, MODA, Empower
Responsibilities
Conduct facility monitoring and product tests, maintain data integrity and compliance with cGMP, author quality system events and new SOPs, troubleshoot problems within QC procedures, perform equipment maintenance and calibrations, train new QC analysts
Seniority
Mid-level individual contributor
