QA Document Control Specialist (GMP & EDMS)

Syngene International; Baltimore, Northern (MD, KY); Hybrid; USD 60,000 - 85,000; Full time

Job summary

Syngene International seeks a QA Analyst I to manage GMP documentation, archival and EDMS-related tasks. You will support technical writing, formatting and ensuring accuracy and consistency of controlled documents, contributing to regulatory compliance and efficient information flow across the site.

The role requires a Bachelor’s in science, 3+ years in cGMP QA documentation, and strong MS Office skills. You will work within a team to maintain document integrity and support training activities

Qualifications

• Bachelor's degree in scientific or related field required.
• 3+ years of cGMP QA documentation experience required.
• Proficiency with MS Office tools (PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, Visio) preferred.
• Excellent organizational, analytical and problem‑solving skills.
• Experience maintaining CGMP compliance and documenting processes.

Responsibilities

• Maintain documentation archival and chain of custody for GMP documents.
• Support documentation compliance and traceability of activities.
• Scan and convert binders into bookmarkable PDF documents.
• Edit PDFs with proper bookmarks and links.
• Ensure latest documents are archived properly and retrievable.
• Achieve SME status on EDMS and reporting tools.
• Collaborate with team to meet documentation and training deliverables.
• Assist with SOP generation and provide SME input to authors.
• Work independently to support business goals.

Education

Bachelor's Degree in Scientific or related fields

3+ years of cGMP in QA documentation

Tools

PowerPoint

Excel

Word

Outlook

Internet Explorer

Access

Visio

Job description

Syngene International seeks a QA Analyst I to manage GMP documentation, archival and EDMS-related tasks. You will support technical writing, formatting and ensuring accuracy and consistency of controlled documents, contributing to regulatory compliance and efficient information flow across the site.

The role requires a Bachelor’s in science, 3+ years in cGMP QA documentation, and strong MS Office skills. You will work within a team to maintain document integrity and support training activities