Document Control and Quality Specialist

CICONIX; Frederick (MD); On-site; USD 55,000 - 58,000; Full time

Benefits offered by this job

Health benefits

PTO

401k + contribution

Job summary

CICONIX is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities for the DHA R&D MRDC team in Fort Detrick, MD. You will prepare, publish, and submit documents in accordance with laws, regulations, and policies for drug, biologic, device, and combination products; provide document control and archiving support for electronic and paper records.

The role requires publishing dossiers to regulatory formats, ensuring audit-ready files, and offering

Qualifications

• 5 years of administrative experience.
• Proficient with Microsoft Word, PowerPoint, Excel, and Outlook.
• Ability to manage and digitize paper records up to 25 lbs.
• U.S. Citizenship with ability to obtain government security clearance.

Responsibilities

• Prepare documents for publishing and regulatory submission in required formats (eCTD, eSTAR, etc).
• Publish dossiers meeting applicable regulations and meet tight deadlines; provide validation reports.
• Perform quality reviews and provide feedback on published dossiers.
• Submit dossiers to the US FDA via the Electronic Submission Gateway and other methods.
• Create and maintain audit-ready regulatory files and Trial Master File (TMF).
• Maintain Sponsor Regulatory Mailbox and upload documents to SERF in the EDMS.

Skills

Administrative experience

Regulatory knowledge

Attention to detail

Communication

Tools

Microsoft Word

PowerPoint

Excel

Outlook

EDMS

Job description

Document Control and Quality Specialist

• Full-time position
• Regular weekly hours (0900-1600)
• Full benefit program, including: health, PTO, & 401k + contribution

Description

Document Control and Quality Specialist

About CICONIX: CICONIX LLC is a Veteran Owned Small Business specializing in business advisory and technical assistance for military health programs. We value exceptional people, unwavering integrity, inclusive collaboration, and enduring impact.

Location(s): Fort Detrick, MD

Position Details

• Full-time position
• Regular weekly hours (0900-1600)
• No calls, nights, weekends, or holidays!
• Full benefit program, including: health, PTO, & 401k + contribution

Requirements

• TBD

Summary

CICONIX is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities (ORA) in support of the Defense Health Agency Research and Development Medical Research and Development Command (DHA R&D MRDC) team in Fort Detrick, MD. The Document Control and Quality Specialist will prepare, publish, and submit documents in accordance with all pertinent laws, regulations, guidance documents, best practices, and policies for drug, biologic, device, and combination product types; provide document control and archiving support for electronic and paper records; and provide publishing, submission, and document control subject matter expertise to ORA and its external partners.

About The Role

• Prepare documents for publishing and submission to regulatory agencies in the required formats, including electronic Common Technical Document, eCOPY, or Electronic Submission Template and Resource (eSTAR) or preSTAR formats.
• Publish dossiers that comply with the applicable regulations, policies, guidance documents, formats, and standards, sometimes with short timelines, to meet regulatory deadlines. Provide Validation reports on the published output.
• Perform quality reviews and provide feedback on published dossiers.
• Submit dossiers to the US FDA through the Electronic Submission Gateway and other methods as required.
• Create and maintain audit ready regulatory files and Trial Master File (TMF).
• Assist the Government by maintaining the Sponsor’s Regulatory Mailbox. The Contractor shall upload the Sponsor’s documents to the Sponsor’s Electronic Regulatory Filing (SERF) in the EDMS. Once the document is uploaded the Contractor will notify the sender that the document was uploaded to SERF.
• Participate in project meetings and communications and provide subject matter expertise and guidance to ORA and external team members.

Qualifications

• Education:
• TBD
• Licensure & Certifications (Current & Unrestricted):
• TBD
• Experience:
• 5 years of administrative experience.
• Proficient use of Microsoft Word, PowerPoint, Excel, and Outlook.
• Manage transport and digitation of paper records, this task may require the ability to lift up to 25 pounds.
• Security & Background Check:
• U.S. Citizenship and a successful background investigation are required.
• Ability to obtain and maintain a government security clearance.
• Additional Requirements:
• Willingness to comply with the government vaccination requirements.

Compensation: $55k - $58k

CICONIX LLC is an Equal Opportunity Employer, including disability/vets. We E-Verify all employees.