Quality Assurance Document Control Specialist
Company Summary: A small privately-owned pharmaceuticals CDMO, specializing in generics, is currently seeking a driven, motivated, and multi-faceted QA Document Control Specialist. This role will be located in the greater Atlanta area. The QA Document Control Specialist will play a critical role in making sure all data and documentation is in GMP compliance.
The QA Document Control Specialist will be responsible for:
- Develop GMP-compliant standard operating procedures (SOPs) and manage document formatting and archiving.
- Coordinate document revisions, maintain tracking databases, and oversee controlled document distribution workflows.
- Review and approve batch-related documentation to ensure compliance with regulatory standards.
- Support manufacturing by issuing batch production records and QC testing results.
- Assist in drafting SOPs, reports, and protocols, and participate in Quality System Improvements.
- Facilitate site training activities, including orientation and coordination of employee training, and contribute to Regulatory inspections and internal audits as required.
The QA Document Control Specialist should have the following qualifications:
- Bachelor's degree in science field
- Minimum of 3 years of experience in quality systems and/or document control
- Strong understanding of regulatory requirements and quality standards applicable to pharmaceutical manufacturing (e.g., FDA regulations, cGMP guidelines).
If you see yourself in this QA Document Control Specialist role and are interested, then please don't wait to apply.
