Quality Analyst Document Control

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

Job Title: QA Analyst I

Department: Quality Assurance

About Syngene

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
• 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 & 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.