QA Document Control Analyst - GMP Compliance

RiseMe; Baltimore (MD); On-site; USD 60,000 - 85,000; Full time

Job summary

Syngene International Ltd. is seeking a QA Analyst I in the Quality Assurance department. The role focuses on scanning, filing, archiving, and maintaining GMP-controlled documents, while supporting technical writing and formatting to ensure accuracy and process flow.

The candidate will handle electronic and paper-based documentation systems, ensuring compliance with regulatory requirements. The position emphasizes daily documentation management, traceability, and collaboration with owners,

Qualifications

• Bachelor’s degree in scientific or related field.
• Minimum 3 years of cGMP QA documentation experience in pharmaceutical industry.
• Proficiency with PC software: PowerPoint, Excel, Word, Outlook, Access, Visio.
• Ability to coordinate multiple priorities in a fast-paced environment.
• Excellent organizational, analytical and problem-solving skills.
• Experience in maintaining CGMP compliance preferred.

Responsibilities

• Maintain documentation archival and record chain of custody and traceability for onsite and offsite documents.
• Execute daily activities supporting documentation compliance and traceability.
• Scan contents into identifiable PDF documents and ensure proper formatting.
• Edit PDFs to ensure bookmarks and links work correctly.
• Verify latest documentation is archived accordingly.
• Achieve SME status on EDMS/facility systems and reporting tools.
• Collaborate with team and site customers to ensure timely deliverables.
• Provide end-user training for document control procedures.
• Assist with SOP generation and review; advise other authors on site.
• Work independently to support business goals and interact with stakeholders.

Skills

Organizational skills

Analytical skills

Problem solving

Communication skills

Education

Bachelor’s degree in science or related field

Tools

PowerPoint

Excel

Word

Outlook

Access

Visio

Job description

Syngene International Ltd. is seeking a QA Analyst I in the Quality Assurance department. The role focuses on scanning, filing, archiving, and maintaining GMP-controlled documents, while supporting technical writing and formatting to ensure accuracy and process flow.

The candidate will handle electronic and paper-based documentation systems, ensuring compliance with regulatory requirements. The position emphasizes daily documentation management, traceability, and collaboration with owners,