QA Document Control Analyst - GMP/EDMS Expert

Syngene International; Baltimore (MD); On-site; USD 55,000 - 72,000; Full time

Job summary

Syngene is seeking a QA Analyst I in Baltimore to manage and archive GMP-controlled documents and support technical writing and formatting for consistency and traceability. You will ensure proper design, storage, and retrieval of papers and electronic records, working with owners and authors to maintain quality documentation.

The role requires a Bachelor’s in a scientific field and at least 3 years of cGMP QA documentation experience, plus proficiency with Microsoft Office tools.

Qualifications

• Bachelor’s Degree in Scientific or related fields.
• A minimum of three (3) years of cGMP in QA documentation in Pharmaceutical industry.
• Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
• The ability to coordinate multiple priorities in a fast-paced environment.
• Excellent organizational, analytical and problem-solving skills.
• Experience in maintaining CGMP compliance preferred.
• Excellent communication skills with the ability to interact with all levels throughout the organization.

Responsibilities

• Ensure maintenance of documentation archival and record chain of custody and traceability for onsite and offsite documents for easy identification and retrieval.
• Execute daily activities that support documentation compliance and traceability to all executed activities.
• Using a systematic approach, scan the contents of various binders and folders into identifiable and properly formatted PDF documents.
• Edit the PDF files to ensure that they are bookmarked and linked appropriately.
• Perform routine verification to ensure latest documentation archived accordingly.
• Achieve and maintain SME status on all functional area application systems and reporting tools for the Electronic Data Management System (EDMS).
• Collaborate with team members and site customers to ensure timely deliverables for documentation and training objectives.
• Provide end user assistance/training for document control procedures.
• SOP generation and review, providing subject matter expertise to other document authors on site.
• Must be capable to work independently and strategically to ensure day-to-day activities are carried out in support of the business goals.
• Frequently interacts with direct manager, peers, internal customers, and other cross functional peers across Emergent.

Education

Bachelor’s Degree in Scientific or related fields

Tools

PowerPoint

Excel

Word

Outlook

Internet Explorer

Access

Visio

Job description

Syngene is seeking a QA Analyst I in Baltimore to manage and archive GMP-controlled documents and support technical writing and formatting for consistency and traceability. You will ensure proper design, storage, and retrieval of papers and electronic records, working with owners and authors to maintain quality documentation.

The role requires a Bachelor’s in a scientific field and at least 3 years of cGMP QA documentation experience, plus proficiency with Microsoft Office tools.