Our client is currently looking to bring on a Quality Control consultant to help revamp and update their SOP’s. Their SOP’s are mainly around QC, microbiology and CMC for a few biologic products. They currently have QC reps for each product line but see some gaps in the SOP’s for the QC area in relation to meeting quality standards. They need this resource to come in and do a gap analyses and then help fill the gaps and strengthen the already written procedures to make them more compliant and transparent.
This resource should come from a QC background so they have functional knowledge of the processes and where any gaps may currently lie. At times, there would be some raw data coming from contract organizations that would also need to be reviewed. If this resource has any CMO oversight experience that would be a plus.
SOP authoring and reviewing
Bachelors degree and 5+ years of experience required
Remote: QC SOP Writer (232795)