Quality Assurance Manager, Silver Spring, United States 135 views

Quality Assurance Manager

Job Locations US-MD-Silver Spring

# of Openings : 1

Type : Regular Full-Time

Overview

CAMRIS International is a medical research and development firm that realizes innovative solutions to health and development challenges through high-quality, cost-effective program and research management services. We combine our proven systems with today’s most effective, evidence-based best practices to improve the lives of people around the world. Our core practice areas include HIV/AIDS, microbiology and infectious disease research, vaccine research, development and production, global health security, biodefense, and clinical research.

CAMRIS is seeking a Quality Assurance Manager to oversee microbiological, serological, environmental, in-house facility system and chemical analysis services for products manufactured at the WRAIR PBF.

*This is a forecasted position and it is contingent upon contract award.

Responsibilities

General Responsibilities

  • Oversees a group of qualified analysts and is responsible for all aspects of quality control testing and data generation
  • Assists with supplying regulatory information (IND submissions, etc.)
  • Maintains a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
  • Coordinates, manages and executes drug substance and drug product stability programs as required
  • Manages Quality Control budget
  • Reports to Quality Director
  • Specific Responsibilities

  • Raw material testing, water and air analysis, environmental monitoring and data trending
  • Upstream, in-process and final product analysis in accordance with cGMP and the Code of Federal Regulations 21 CFR 58, Good Laboratory Practices (GLP).
  • Generation of product testing summary reports and Certificates of Analyses generation (supporting QA)
  • Supports periodic Quality Management Review with EM data as required
  • Other duties as required
  • Qualifications

  • 15+ years managing Quality systems in a cGMP manufacturing facility
  • Experience in QA in the areas of documentation control, raw material management, instrument calibration, validation, repair, facility system controls, internal and external audit competency and compliance training
  • Must possess skills using various types of analytical and laboratory equipment
  • Direct and matrix managerial experience
  • Proficient at Microsoft office, especially MS Excel and Word
  • Preferred Skills

  • MS or MBA in related discipline
  • Experience in QA oversight of both drug substance and drug product manufacturing
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