Our client is looking for several Deviations Writers to come in and assist with the backlog of deviations they need done by mid- February the latest. They will be needed for the operations piece for deviation support, they already have a team of QA folks to support the closure of the deviations so they will be needed primarily for manufacturing operations deviations.
Strong biologics experience
Strong understanding of unit operations – cell culture, bioreactor, TFF, Chromatography, filtrations, etc.
Strong knowledge of Single use disposable systems
Preferred experience in manufacturing but quality and/or validation setting experience is acceptable as long as unit ops familiarity exists
Proven experience with authoring, reviewing, approving deviations/non-conformances
Trained with understanding of RCA techniques – 5Whys, 6Ms, fishbone, etc.
Have worked with batch records and have familiarity with workings of cGMP mfg environment
Life science or engineering degree with at least 5+ yrs of direct relevant exp.
Use of TrackWise system or similar operating framework
Strong writing skills is a must
MD: CAPA/Process Engineer (3 spots) (232137)