Regulatory Doc Lead: GMP Compliance & Audits (Hybrid)

ATCC Biotechnology; Innovation (VA); On-site; USD 60,000 - 65,000; Full time

Benefits offered by this job

Health insurance

Life Insurance

Disability Insurance

AD&D

Parental leave

Paid holidays

PTO

401(a) employer contribution

403(b) matching

Legal services

Pet insurance

Career advancement opportunities

Job summary

ATCC Biotechnology in Manassas, VA is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and permits across our global materials programs. You will create, review, and maintain controlled documents and ensure audit readiness in a hybrid work environment.

The role focuses on regulatory submissions, permit management, and lifecycle governance, with opportunities for professional advancement within our growing compliance team.

Qualifications

• High School Diploma and 2 years of regulated-environment experience.
• Experience managing controlled documentation within GMP or regulated manufacturing settings.
• Proficiency drafting and maintaining SOPs and related documents.

Responsibilities

• Extract, analyze, and summarize documentation for regulatory submissions, audits, and inspections.
• Maintain, control, archive, and distribute regulated documents in line with GMP and quality systems.
• Author, revise, and review SOPs and related documentation.
• Manage document lifecycles, approval workflows, and retention practices.

Skills

Regulatory documentation

SOP authoring

Audits & inspections

GMP knowledge

Cross-functional communication

Education

High School Diploma

Tools

Electronic Document Management Systems

Job description

ATCC Biotechnology in Manassas, VA is seeking a Senior Regulatory Document Specialist to support regulatory compliance activities and permits across our global materials programs. You will create, review, and maintain controlled documents and ensure audit readiness in a hybrid work environment.

The role focuses on regulatory submissions, permit management, and lifecycle governance, with opportunities for professional advancement within our growing compliance team.