Document Control and Quality Specialist

Clearance Level
None
Category
Quality Assurance
Location
Fort Detrick, Maryland

REQ#: RQ135743

Travel Required: Less than 10%
Public Trust: NACI (T1)
Requisition Type: Regular

GDIT's Military Health team is hiring a Document Control and Quality Specialist to support a Publishing and Document Control component of a military medical research and regulatory affairs, Office of Regulated Activities (ORA), United States Army Medical Research and Development Command (USAMRDC) under the DoD (Dept. of Army) located at Ft. Detrick in Frederick, Maryland.

The Office of Regulated Activities (ORA) is a multidisciplinary team of regulatory affairs, compliance, and clinical support professionals dedicated to supporting the USAMRDC mission of developing Food and Drug Administration regulated medical products for the Warfighter. The ORA provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, biostatistics, product technical, safety monitoring, and medical and regulatory writing support for FDA-regulated drug, biologic, medical device, and combination products.

This position is based in the Ft. Detrick and Frederick, Maryland.

Responsibilities:  

  • Provide document control and archiving support for the sponsor’s electronic regulatory files and essential documents, transition of paper records to electronic media, and preparation of hard copy documents for off-site storage. Document control and archiving support includes but is not limited to the following

  • Create and maintain audit ready (ensure or evaluate compliance with the designated quality system and applicable regulatory requirements) sponsor’s electronic regulatory files and related essential documents provided by integrated product team or working group team members

  • 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 ORA personnel or other integrated product team or working group 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, which includes physically moving boxes up to 25 pounds

  • Maintain a log and track hard copy and electronic historical and current sponsor’s files and clinical trial site documents 

  • Provide subject matter expertise and guidance to ORA personnel or other integrated project teams or working group members

  •  Attend meetings as required

  • Collaborate with ORA personnel to remediate any issues

  • Provide subject matter expertise and support for the development and implementation of in-house quality systems and procedures to support ORA compliance

Required Qualifications:

  • Bachelor’s degree

  • 5+ years of experience in relevant roles such as document control specialist and index control specialist

  • Must have advanced proficiency with MS Office Suite (especially MS Excel)  

  • Exceptional communicator with ability to adjust communication style to individual personalities and needs of our customers

  • Must be adept in prioritizing multiple tasks in a fast-paced customer-centric environment

  • Must be U.S. citizen and be able to obtain a TI (Public Trust) clearance.

WHAT GDIT CAN OFFER YOU: 

  • Challenging work that makes a real impact on the world around you  

  • Internal mobility team dedicated to helping you own your career 

  • 401K with company match 

  • Diverse, highly collaborative teams

  • Professional development, education assistance, certification and training opportunities

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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.

COVID-19 Vaccination

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.