Remote: Senior GMP/ QC Consultant (226438)

Life Sciences & Technology | Quality Assurance & Quality Control

Location: Remote

Duration: At least through end of the year.

Job Description:

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.

Responsibilities:

  • 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.

Requirements:

  • 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

#LI-BR1

Start Date
ASAP
Location
South

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