QA Documentation Specialist

Company Description

QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields.

Log on now to our website http://www.qrcgroup.com/ to learn more about our services and solutions!

Job Description

Quality Assurance Specialist with strong expertise in GMP documentation and quality systems. This role blends traditional QA responsibilities with a focus on managing, reviewing, and controlling documentation to support compliance and operational excellence.

Key Responsibilities:

• Review, approve, and maintain GMP documentation including batch records, protocols, CAPAs, NOEs, and change controls.
• Ensure documentation aligns with regulatory requirements and internal quality standards.
• Support internal audits, inspections, and document readiness for regulatory agencies.
• Collaborate with cross-functional teams to implement document revisions and updates.
• Manage document control systems and ensure timely issuance and archiving of controlled documents.
• Assist in training personnel on documentation procedures and compliance practices.

Qualifications

• Bachelor’s degree completed.
• Minimum 5 years of experience.
• Strong background in GMP documentation and quality systems.
• Proficiency in document control platforms and Microsoft Office tools.
• Excellent attention to detail, organizational skills, and written communication.
• Ability to work independently and in cross-functional environments.

Additional Information

All your information will be kept confidential according to EEO guidelines.