Duration: At least through end of the year.
A Black Diamond biotech client in Cambridge, MA is looking for a Sr. QC GMP Consultant with 10+ years experience to write overall quality master plan for tech transfer and ensuring protocols written by research teams meet the proper requisites for FDA compliance.
- Complete documents and protocols.
- Ensure final reports are in a state that everyone understands.
- Creating a variety of documents, help write master plan, tech transfer, help from quality side.
- Client needs an individual with a background in quality who knows what should be in a protocol, what should be in a flow assay (not a scientist or validation person)
- Need someone with GMP background who knows what FDA is looking for, how protocol should be written.
- Both QC/QA background, mainly QC, understands regulatory requirements.
- Need to understand flow assays.
- Ideally cell therapy person, this a biologic product.
- Biologic or cell therapy background.
- Work with living cells, flow cytometry background.
- Skills: QC, Biologics, GMP, Protocols
- Education: Biology, not looking for chemistry.
JOB ID# 226438