Senior Regulatory Documentation Specialist – Hybrid, GMP

ATCC; Manassas (VA); Hybrid; USD 60,000 - 65,000; Full time

Benefits offered by this job

Health & Wellness coverage

401(a) retirement plan

403(b) retirement match

Corporate bonus program

Paid holidays & PTO

Job summary

ATCC in Manassas, VA, is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and assigned compliance projects in a hybrid role. You will create, review, maintain, and communicate governing documentation for biological materials handling and regulatory permits, while supporting regulatory submissions and audits.

The role requires 2+ years of regulatory/document control experience in a GMP-like environment, experience authoring SOPs, and the ability to work

Qualifications

• Must have 2+ years of regulatory/document control experience.
• Experience working in GMP/regulatory environments.
• Proficiency in authoring and maintaining SOPs and controlled documents.

Responsibilities

• Extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections.
• Maintain, control, archive, and distribute regulated documents and records to ensure audit readiness.
• Author, revise, and review SOPs, work instructions, forms, and related documentation.
• Manage document lifecycles, approval workflows, and retention practices.

Skills

Regulatory docs

SOP authoring

Audit support

Cross-functional comms

Education

High School Diploma

Tools

Document management systems

Job description

ATCC in Manassas, VA, is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and assigned compliance projects in a hybrid role. You will create, review, maintain, and communicate governing documentation for biological materials handling and regulatory permits, while supporting regulatory submissions and audits.

The role requires 2+ years of regulatory/document control experience in a GMP-like environment, experience authoring SOPs, and the ability to work