Regulatory Documents Coordinator: SOPs & Compliance

Global Solutions Network Inc; Bethesda (MD); On-site; USD 87,000 - 115,000; Full time

Benefits offered by this job

Paid Time Off

Paid Holidays

401K/Profit Sharing Plan

Flexible Spending Accounts

Pretax Parking & Transportation Plan

Short-Term & Long-Term Disability

Life & AD&D Insurance

Professional Development/Education

Employee Discount Program

Employee Assistance Program

Travel Assistance Program

Job summary

Global Solutions Network Inc is seeking a Regulatory Document Coordinator to support NIH. The role involves managing SOPs, WIs, and training modules, ensuring proper version control, approvals, and controlled distribution within the DFOM/BSL environments.

Candidate should have a Bachelor's degree, experience in biomedical labs, and knowledge of GMP regulatory documents, with strong organizational and communication skills.

Qualifications

• Bachelor's degree in a relevant field is required.
• Experience working in biomedical laboratory settings is required.
• Knowledge of regulatory documents related to Good Manufacturing Practice (GMP) is required.
• Strong organizational, written, and interpersonal skills are essential.

Responsibilities

• Document lifecycle management for SOPs, WIs, and Training Modules.
• Coordinate periodic reviews to keep documents current and technically accurate.
• Manage revision tracking and incorporate approved edits.
• Facilitate approvals within established time-frames.
• Distribute documents to ensure access to current versions.
• Archive superseded or obsolete documents.

Skills

Regulatory document management

Attention to detail

Cross-team communication

Education

Bachelor's degree

Job description

Global Solutions Network Inc is seeking a Regulatory Document Coordinator to support NIH. The role involves managing SOPs, WIs, and training modules, ensuring proper version control, approvals, and controlled distribution within the DFOM/BSL environments.

Candidate should have a Bachelor's degree, experience in biomedical labs, and knowledge of GMP regulatory documents, with strong organizational and communication skills.