Our client needs GLP Expert to assist with authoring of SOP’s within lab operations while adhering to GLP requirements. The client has new labs being set up with LIMS & equipment. This individual will need to be someone who has strong technical expertise and a working background within GLP requirements (i.e., lab set up, lab inspections, lab requirements to meet local & FDA requirements, etc).
The most critical SOP’s that are requiring attention/authoring consist of lab operation management SOP’s such as (but not limited to): Assay management procedures, qualification management procedures, education qualification policies, training process policies, competency evaluation procedures, reagent SOP’s, etc. There are about 100 SOP’s within the lab operations as well as about 40 SOP’s within Quality that are needing to be completed. The company has a template that they utilize for SOP’s, however, the SOP’s are essentially blank and require authoring from top to bottom.
Once SOP’s are written, they will be sent for review for final approval (re-drafting/writing may take place if advised after review). The resource for this project will need to be self-sufficient and work independently and having prior expertise within the above scope of work, as there will be minimal supervision on this project. Laboratory working environment and GLP expertise is required. Candidates who also carry expertise in authoring Quality-based SOP’s, CAR-T studies, and with previous positions as a Lab Manager or similar will be beneficial (not required).
Position: GLP SOP Writer
Duration: 3 months to start (extensions for the right fit)
Hours per week: 20-40 (flexible schedule – there could be weeks with less than 20)
Start Date: Immediate
Remote: GLP SOP Writer (232076)