Quality Analyst Document Control

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

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Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene' s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

At Syngene, safety is at the heart of everything we do personally and professionally. Syngene has placed safety at par with business performance with shared responsibility and accountability, including following safety guidelines, procedures and SOPs, in letter and spirit.

Job Summary:

The QA Analyst I will be responsible for scanning, filing, archiving, organizing, and maintaining an inventory of documents as well as assisting employees in providing assistance for technical writing and formatting documents for consistency, accuracy, and process flow to owners and authors of documents. They are accountable for the execution of daily activities as related to documentation record management, archive, and retrieval of GMP controlled documents ensuring the site complies with relevant regulations. The role will contribute to organizational management on all electronic and paper-based systems that support daily activities of documentation management and proper design.

Primary 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
• 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 & 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

Additional requirements for this role:

Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyse/interpret, problem solve, make decisions, plan, communicate and prepare written communications.

Equal Opportunity Employer:

It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, colour, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.