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Document Control and Quality Specialist

General Dynamics Information Technology • Fort Detrick, MD • 4h ago

Req ID: RQ207369

Type of Requisition: Regular

Clearance Level Must Be Able to Obtain: None

Public Trust/Other Required: NACI (T1)

Job Family: Professional Engineering

Skills:

Document Controls,Electronic Documentation Management Systems,Electronic Filing

Experience:

5 + years of related experience

US Citizenship Required:

Yes

Job Description:

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

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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The likely salary range for this position is $94,676 - $128,092. This is not, however, a guarantee of compensation or salary. Rather, salary will be set based on experience, geographic location and possibly contractual requirements and could fall outside of this range.

Our benefits package for all US-based employees includes a variety of medical plan options, some with Health Savings Accounts, dental plan options, a vision plan, and a 401(k) plan offering the ability to contribute both pre and post-tax dollars up to the IRS annual limits and receive a company match. To encourage work/life balance, GDIT offers employees full flex work weeks where possible and a variety of paid time off plans, including vacation, sick and personal time, holidays, paid parental, military, bereavement and jury duty leave. To ensure our employees are able to protect their income, other offerings such as short and long-term disability benefits, life, accidental death and dismemberment, personal accident, critical illness and business travel and accident insurance are provided or available. We regularly review our Total Rewards package to ensure our offerings are competitive and reflect what our employees have told us they value most.

We are GDIT. A global technology and professional services company that delivers consulting, technology and mission services to every major agency across the U.S. government, defense and intelligence community. Our 30,000 experts extract the power of technology to create immediate value and deliver solutions at the edge of innovation. We operate across 50 countries worldwide, offering leading capabilities in digital modernization, AI/ML, Cloud, Cyber and application development. Together with our clients, we strive to create a safer, smarter world by harnessing the power of deep expertise and advanced technology.

Join our Talent Community to stay up to date on our career opportunities and events at https://gdit.com/tc.

Equal Opportunity Employer / Individuals with Disabilities / Protected Veterans

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