Our client is currently looking to bring on a Quality Control consultant to help a team of QC analysts with OOS investigations and other quality control activities. This resource will look over the in process testing, final testing and stability testing to ensure there are no out of specification results. If one is found, this person will need to initiate the investigation and do the FDA phase 1-3 OOS investigations. This resource will also be looking out for any other quality events that may take place, (items stored incorrectly, delayed stability testing, etc.) and will lead the investigation to obtain appropriate data to resolve said events. The client currently has approximately 20 quality events that they are investigating concurrently so there will also need to be a daily check on the status of these investigations and help close them out appropriately.
It would be ideal if this person has an understanding of the upstream/downstream manufacturing process and has worked in both a microbiology and biochemistry lab. Anyone with prior FDA experience would be perfect.
Out of Specification Investigation
Bachelors degree and 5+ years of experience required
ND: QC investigation (232898)