Regulatory Document Coordinator - NIH

Global Solutions Network Inc • Bethesda, MD

9d • $87,000 - $115,000 • Onsite

About The Position

Global Solutions Network (GSN), a federal government contracting firm, presents this full time, long-term position supporting GSN's customer at the National Institutes of Health (NIH). This position provides a competitive salary and comprehensive benefits.

Requirements

• Bachelor's degree in a relevant field.
• Experience working in biomedical laboratory settings.
• Demonstrated knowledge of regulatory documents related to Good Manufacturing Practice.
• Strong organization, written, and interpersonal skills.

Responsibilities

• Manage the full lifecycle of Standard Operating Procedures (SOPs), Work Instructions (WIs), and Training Modules for Division of Facilities Operations and Maintenance (DFOM) Aseptic Processing Facilities (APF) and Biosafety Level (BSL) operations, including initial creation and drafting, coordination of periodic review cycles, management of the revision process, facilitation of the approval process, management of distribution, and management of document retirement and expiration.
• Utilize the NIH document control system to ensure compliance with organizational and regulatory record keeping requirements, including maintenance of detailed version control records, tracking of authorship, maintenance of complete revision history, tracking of approval status, recording and monitoring effective dates, and monitoring of document expiration timelines.
• Coordinate document review activities and manage controlled access to current documentation, including coordination of cross-functional reviews, verification of document content consistency with DFOM policies and procedures, verification of alignment with industry standards and regulatory requirements, oversight of controlled distribution processes, and removal or restriction of access to superseded or expired document versions.
• Track and manage personnel training status in direct linkage with the document control system, including linking Training Modules to SOPs and WIs, tracking individual employee training status, monitoring completion within designated time-frames, maintaining up-to-date training records, generating compliance reports, and supporting internal and external audits.

Benefits

• Medical, Dental, & Vision Coverage
• Paid Time Off and Paid Holidays
• 401K/Profit Sharing Plan
• Flexible Spending Accounts (Healthcare & Dependent Care)
• Pretax Parking & Transportation Plan
• Short-Term & Long-Term Disability Insurance
• Life & AD&D Insurance
• Professional Development/Education
• Employee Referral Bonuses
• Employee Discount Program
• Merit Bonuses
• Employee Assistance Program
• Travel Assistance Program

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level