Regulatory Document Control & Quality Specialist

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

Benefits offered by this job

Full benefits including health, PTO, 4

401k + contribution

Job summary

CICONIX LLC is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities (ORA) in Fort Detrick, MD. The role will prepare, publish, and submit documents in accordance with applicable laws and guidance for drug, biologic, device, and combination products.

The Specialist will provide document control and archiving support for electronic and paper records, and offer publishing, submission, and document control expertise to ORA and external partners.

Qualifications

• 5 years of administrative experience.
• Proficient use of Microsoft Word, PowerPoint, Excel, and Outlook.
• Ability to lift up to 25 pounds.

Responsibilities

• Prepare documents for publishing and submission to regulatory agencies in required formats (e.g., eCTD, eCopy, eSTAR).
• Publish dossiers that comply with regulations and meet deadlines; provide validation reports.
• Perform quality reviews and provide feedback on published dossiers.
• Submit dossiers to the US FDA through the Electronic Submission Gateway and other methods.
• Create and maintain audit-ready regulatory files and TMF.
• Assist the Government by maintaining the Sponsor’s Regulatory Mailbox and uploading documents to SERF.
• Participate in project meetings and provide SME guidance to ORA and external team members.

Skills

Administrative experience

Microsoft Word

Document management

Tools

PowerPoint

Excel

Outlook

Job description

CICONIX LLC is seeking a Document Control and Quality Specialist to support the Office of Regulated Activities (ORA) in Fort Detrick, MD. The role will prepare, publish, and submit documents in accordance with applicable laws and guidance for drug, biologic, device, and combination products.

The Specialist will provide document control and archiving support for electronic and paper records, and offer publishing, submission, and document control expertise to ORA and external partners.