QC Raw Material Manager
- Job type Contract
- Salary competitive
- Location Cambridge, Massachusetts
- Sector Pharma & Biotech, Quality & Supply Chain, Clinical Research, Operations, Regulatory Affairs
Senior Associate/manager-Quality control
The Successful Candidate will be part of Quality Control will be responsible for leading the completion of material specification processes related to on boarding new or revised existing raw materials. This role requires ability to work collaboratively with raw material vendors, Quality Control, process analytical sciences, manufacturing, and quality assurance departments to ensure raw material specification packages while meeting regulatory expectations
-Assist with devising and establishing the raw material specifications for the Norton Manufacturing Facility in collaboration with Process and Analytical Sciences, Manufacturing, QA, and QC SMEs.
-Generate and/or revise necessary documentation (e.g., raw material request form, change controls, risk assessment, material number request, risk assessments, classification, specifications and their justifications, etc.) for new and existing raw materials.
-Coordinate activities to ensure all specification-related documentation are complete and meet regulatory standards
-BS degree or equivalent
-10+ years of GMP QC laboratory or biotech/pharmaceutical experience
-Expertise in the raw materials program, including a clear understanding of various regulatory requirements
-Direct involvement in material specification setting and justification is preferred
-Experience with USP, Ph EUR, GMP and JP compendial requirements
Sthree US is acting as an Employment Business in relation to this vacancy.