Quality Assurance Manager
Job Locations US-MD-Silver Spring
# of Openings : 1
Type : Regular Full-Time
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.
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
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
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
MS or MBA in related discipline
Experience in QA oversight of both drug substance and drug product manufacturing