Job Description
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.
Required Skill
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)
