QC Manager

Standort: Irvine, California Gehalt: negotiable
Bereich: Pharma & Health Bereich: Freiberufler
Reference #: CR/072989_1597239619

Red is seeking a QC Manager for a pharmaceutical client based in Irvine, California. This person must be onsite Mon-Friday and the project will go through April 2021.

Position summary:

  • Provides guidance and technical expertise to QC Chemistry personnel in all areas of Quality Control functions, including finished product, raw material and stability.
  • Oversee the Chemistry laboratory activities, including analytical site transfers, testing and approval or rejection of raw materials, packaging materials, in process materials and finished products (including stability).
  • Oversee/approve investigations, ensuring they are being conducted according to approved procedures and that corrective and preventive actions are implemented and effective.
  • Ensure QC documentation is handled and archived according to the relevant approved procedures.
  • Oversee and ensure adequate maintenance of the laboratory equipment and systems and monitoring of the laboratory environment.
  • Establish and implements departmental policies and ensures compliance to cGMP, cGLP, FDA, and other applicable regulatory guidelines.

Required experience:

  • B.S. in Chemistry with a minimum of 10 years of work experiences in Pharmaceutical Chemistry Laboratory or related industry.
  • Minimum of 10-15 years of work experience in Pharmaceutical Chemistry Laboratory or related industry.
  • Minimum of 5-6 years of supervisory and management experience.
  • In-depth knowledge of cGMPs, GLP, USP, BP and EP Chemistry test methods and requirements and FDA, EMEA and other regulatory guidelines.
  • Thorough knowledge of Chemistry methods, lab equipment, and operation of LIMS system.
  • Excellent communication skills when communicating with senior management, colleagues, peers and management of other departments, etc. Possess good mentoring capabilities.
  • Demonstrates strong technical skills.
  • Strongly preferred experience in sterile/aseptic manufacturing operations and laboratory methods