GDIT has an opportunity for a full-time Quality Assurance Advisor in support of the Influenza Division of Centers for Disease Control and Prevention’s (CDC) working from the Clifton Rd campus in Atlanta, Georgia.
The ideal candidate will strengthen the Influenza Division laboratory quality system compliance to ensure that the vaccine candidate viruses provided for seasonal or pandemic vaccine production meet the highest possible quality standards. In addition, will demonstrate knowledge in quality systems and other regulatory requirements for production of influenza vaccine candidate viruses and provide quality services to comply with Good Laboratory Practices (21 CFR Part 58) for Non-clinical laboratory studies for candidate vaccine viruses produced at CDC as outlined by FDA and other applicable international standards, including those established by the World Health Organization.
Biological materials produced from these efforts will be used to meet pandemic preparedness goals and support seasonal influenza vaccine production. This is an outstanding opportunity to support the Vaccine Preparedness Team (VPT) and work with the nation’s lead agency charged with protecting the public's health.
Maintains the inventory of reagents and supplies for GLP studies
Maintains the equipment master list, including calibration and maintenance schedule
Orders, or assists with orders, and inspects reagents and supplies
Ensures the completion of Equipment qualification plans, IQ/OQ and PQ forms for new equipment
Reviews batch production records and Quality Control Test Records of Candidate Vaccine Viruses (CVV)
Collaborates with laboratory scientists to prepare and maintain the CVV Master Files including maintaining a master schedule of all studies conducted, inspecting studies as necessary to ensure the integrity of the study, and communicating with CDC contract laboratories to ensure all contract deliverable goals are met.
Organizes and sends the CVV Master File to CDC Quality Manager and CDC Regulatory Affairs for FDA submission
Conducts GLP and QMS training for new laboratory staff
Ensures all non-conformance events are investigated and documented
Assists in development of assay and method validation/verification procedures for lot release testing
Communicates progress orally and in writing with technical monitor and other researchers
THE FOLLOWING REQUIREMENTS MUST BE MET TO BE CONSIDERED FOR THIS POSITION:
Ph.D./MS/BS in related field (Chemistry, Biology, Microbiology, or Chem. Eng.)
Experience auditing quality management systems
Certified Quality Auditor
Must have appropriate knowledge of GLP regulatory practices
Must have one year or more of quality experience in microbiology/diagnostic, CLIA and or ISO certified laboratories, medical device manufacturing, pharmaceutical industry or similar
Must have appropriate knowledge of Quality Control processes
Demonstrated interpersonal and management skills with ability to work collaboratively with other scientists and laboratorians
A bioterrorism risk assessment for handling select agents may be required
Ability to obtain and maintain a CDC security clearance
Experience using Microsoft Applications such as Word, Excel, PowerPoint and SharePoint
Ability to multi-task and work in a fast-paced environment
THE FOLLOWING REQUIREMENTS ARE DESIRED:
Experience in the FDA and WHO regulatory environment for vaccines, biologics and/or pharmaceuticals
Experience with Project Management
Experience with Method Validation and Equipment Qualification including writing and review of protocols
Experience writing technical or scientific summaries
Certified Quality Auditor
About Our Work
We are GDIT. The people supporting some of the most complex government, defense, and intelligence projects across the country. We deliver. Bringing the expertise needed to understand and advance critical missions. We transform. Shifting the ways clients invest in, integrate, and innovate technology solutions. We ensure today is safe and tomorrow is smarter. We are there. On the ground, beside our clients, in the lab, and everywhere in between. Offering the technology transformations, strategy, and mission services needed to get the job done.
GDIT does not have a vaccination mandate applicable to all employees. To protect the health and safety of its employees and to comply with customer requirements, however, GDIT may require employees in certain positions to be fully vaccinated against COVID-19. Vaccination requirements will depend on the status of the federal contractor mandate and customer site requirements.
GDIT is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other protected class.