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Job Details

Quality Control Manager Head

Location
Silver Spring, MD, United States

Posted on
Jul 10,2019

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Job Description:
Overview

CAMRIS International is an 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 Control Manager who will d irect and develop testing for microbiological, serological, environmental, in-house facility system and chemical analysis services, as it relates to the products manufactured at a Bioproduction Facility in Silver Spring, MD.

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

Responsibilities


Oversee a group of qualified analysts and is responsible for all aspects of quality control testing and data generation.
Conducting raw material testing, water and air analysis, environmental monitoring and data trending, as well as upstream, intermediate and final product analysis in accordance with current Good Manufacturing Practices (cGMP) and the Code of Federal Regulations 21 CFR 58, Good Laboratory Practices (GLP).
Maintain a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
Participate in the generation of product testing summary reports and Certificates of Analyses generation in conjunction with the quality analysis (QA) unit.
Qualifications


A BA/BS in Engineering or Science and at least six years of experience in quality control relating to testing biological material.
At least six years of experience in quality control relating to testing biological material and documented GLP and GMP experience.
Must possess skills using various types of analytical and laboratory equipment, as well as proficiency with IBM compatible software including spreadsheet programs and word processing programs.
Must also have two years managerial/supervisory experience.
All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).
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Conducting raw material testing, water and air analysis, environmental monitoring and data trending, as well as upstream, intermediate and final product analysis in accordance with current Good Manufacturing Practices (cGMP) and the Code of Federal Regulations 21 CFR 58, Good Laboratory Practices (GLP).
Maintain a validated and calibrated laboratory that will generate data used for Investigational New Drug submissions to the FDA.
Participate in the generation of product testing summary reports and Certificates of Analyses generation in conjunction with the quality analysis (QA) unit.
Qualifications

A BA/BS in Engineering or Science and at least six years of experience in quality control relating to testing biological material.
At least six years of experience in quality control relating to testing biological material and documented GLP and GMP experience.
Must possess skills using various types of analytical and laboratory equipment, as well as proficiency with IBM compatible software including spreadsheet programs and word processing programs.
Must also have two years managerial/supervisory experience.
All proposed personnel to perform services contractor must verify employment eligibility (E-Verify) and obtain a favorable National Agency Check (NACI).

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