General Dynamics Information Technology – Federal Civilian Division is looking for a Document Control and Quality Specialist to join our team to support the Department of Army. This position is based in the Ft. Detrick and Frederick, Maryland areas.
In this role, the Document Control and Quality Specialist will:
Create and maintain audit ready sponsor’s electronic regulatory files and related essential documents.
Assist the Government in electronic capture (scanning) of regulatory documents in a qualified Government-specified electronic document management system for inclusion in the sponsor’s electronic regulatory files.
Provide consultation and training to team members for essential documents that need to be stored in the sponsor’s electronic regulatory files.
Perform a final clinical trial close-out of the sponsor’s electronic regulatory files.
Transition paper records to electronic media.
Prepare hard copy documents for off-site storage (archival) per AR 25-400.
Maintain a log and track hard copy and electronic historical and current sponsor’s files and clinical trial site documents.
Provide expertise and support for the development and implementation of in-house quality systems and procedures to support compliance.
Ensuring quality requirements and management activities in support of medical product development for all product types as per 21 CFR and ICH.
Perform independent reviews and provide reports of documentation, sites, organizations, and facilities to ensure compliance with quality requirements for medical product development and clinical studies as per applicable regulations, standards, and FDA guidance
Participate in special projects as required.
Bachelor’s Degree in a related discipline, or the equivalent combination of education, professional training, or work experience.
5 years of related experience in conducting document control and quality in a regulatory environment.
Excellent Microsoft Office Skills.
Excellent written and oral communication skills.
Must be U.S. citizen and be able to obtain a TI (Public Trust).
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 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.