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Quality Control Manager

Details

  • Location Greater Boston Area, MA
  • Job Type Direct
  • Pay $100,000.00 $20.00 / Hour
  • Category SCIENCE/LAB
  • Date Posted Nov 09, 2017

Overview

About the Company

We are currently looking to hire a Quality Control Manager for an integrated Contract Development and Manufacturing Organization. The company operates out of a state of the art cGMP facility designed to provide optimum efficiency, safety and regulatory compliance. This is an outstanding opportunity to have a management role within a company offering cutting-edge product development technologies and the high quality results for clients.

Responsibilities

  • Overseeing the operations of the QC lab group (10-15) to ensure accurate results, adherence to cGMP FDA regulations, company protocols, and timely completion of projects.
  • Providing expert guidance to Manufacturing, Production, R&D, and other departments regarding quality and cGMP issues.
  • Setting and reviewing performance goals for the QC lab group.
  • Preparing and/or reviewing documentation required for regulatory submissions.

Qualifications

  • Bachelor Degree or above in Chemistry, Analytical Chemistry or related majo
  • At least 10 years+ professional experience with management responsibilities within pharmaceutical Quality Control.
  • At least 5 years of pharmaceutical testing experience in a cGMP-regulated laboratory environment.
  • Knowledge of cGMP, USP/NF, ICH, DEA, EU and FDA guidelines and regulations.
  • Ability to troubleshoot analytical methods and laboratory instrumentation (e.g. HPLC, GC, Dissolution, wet chemistry).
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