Quality Control Associate I
Core
Assist in planning, preparation, and execution of laboratory-based activities for testing and releasing cGMP biological material for early Phase Clinical trials.
Role type
Quality Control Associate I (cGMP biological manufacturing)
Builds
cGMP biological material for early Phase Clinical trials
Domain
Biotechnology / Clinical Research / cGMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP quality system knowledge, cleanroom operations (ISO 5), BSL-1/2/3 biological safety protocols, media and solution preparation, batch record execution, upstream/downstream processing support, fill/finish activities
Preferred skills
contract manufacturing experience, BSL-2/3 clean room experience
Technologies
cell culture, UF/DF, chromatography
Responsibilities
Execute approved documentation for media and solution preparation, assist in batch record execution for upstream/downstream/fill-finish activities, perform activities in cleanroom and BSL environments
Seniority
Entry-level, hands-on IC