Regulatory Quality Documentation Specialist

Efficient Auditing; Atlanta (GA); On-site; USD 70,000 - 90,000; Full time

Job summary

Efficient Auditing seeks a skilled Quality Documentation & Technical Writer to develop, organize, and maintain controlled documents aligning with regulatory standards. Focus on SOPs, validation docs, training materials, and quality manuals to support compliant daily operations.

Collaborate with QA, operations, engineering, and regulatory teams to ensure documents meet standards and support audit readiness. Strong writing, detail orientation, and QMS experience are essential for success.

Qualifications

• Bachelor’s degree in Life Sciences, Technical Communication, Engineering, or a related discipline.
• 2–6 years of experience in technical writing, documentation management, or quality systems support.
• Strong understanding of ISO standards, GMP regulations, and quality documentation structure.
• Excellent written communication skills with exceptional attention to detail.
• Experience working with Document Control or QMS platforms.
• Ability to work with cross-functional teams and translate technical information clearly.

Responsibilities

• Develop, revise, and maintain controlled documents including SOPs, policies, forms, templates, batch records, and quality manuals.
• Support document lifecycle management, ensuring timely updates, version control, and compliance with QMS requirements.
• Work with subject matter experts to translate technical concepts into clear, structured, and user-friendly documents.
• Prepare validation documentation such as URS, IQ/OQ/PQ protocols, reports, and risk assessments.
• Ensure all documents comply with FDA, ISO, GMP, and industry-specific guidelines.
• Assist with internal and external audit preparation by providing accurate and well-organized documentation.
• Develop training materials and support onboarding for new QMS or process changes.
• Recommend improvements in documentation structure, formatting, terminology consistency, and workflow efficiency.
• Support clients transitioning from paper-based systems to electronic documentation or QMS platforms.

Skills

Technical writing

Cross-functional collaboration

Attention to detail

Regulatory documentation

Education

Bachelor’s degree in Life Sciences, Technical Communication, Engineering, or related

Tools

Document Control systems

QMS platforms

Job description

Efficient Auditing seeks a skilled Quality Documentation & Technical Writer to develop, organize, and maintain controlled documents aligning with regulatory standards. Focus on SOPs, validation docs, training materials, and quality manuals to support compliant daily operations.

Collaborate with QA, operations, engineering, and regulatory teams to ensure documents meet standards and support audit readiness. Strong writing, detail orientation, and QMS experience are essential for success.