Document Control and Quality Specialist

General Dynamics • Frederick, MD

143d • $94,676 - $128,092

About The Position

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. Must be able to go onsite 2-3 days a week.

Requirements

• 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 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.

Responsibilities

• Provide document control and archiving support for the sponsor's electronic regulatory files and essential documents.
• Transition paper records to electronic media and prepare hard copy documents for off-site storage.
• Create and maintain audit ready sponsor's electronic regulatory files and related essential documents.
• Assist the Government in electronic capture of regulatory documents in a qualified Government-specified electronic document management system.
• Provide consultation and training to ORA personnel or other integrated product team or working group members for essential documents.
• Perform a final clinical trial close-out of the sponsor's electronic regulatory files.
• 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.
• Attend meetings as required and collaborate with ORA personnel to remediate any issues.
• Support the development and implementation of in-house quality systems and procedures to support ORA compliance.

Benefits

• 401K with company match.
• Diverse, highly collaborative teams.
• Professional development, education assistance, certification and training opportunities.
• Full flex work weeks where possible.
• Variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave.
• Short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Transportation Equipment Manufacturing
• Education Level: Bachelor's degree