Quality Analyst Document Control

Syngene International Limited • Baltimore, MD

2d

About The Position

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.

Requirements

• 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
• Excellent communication skills with the ability to interact with all levels throughout the organization
• 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.

Nice To Haves

• Experience in maintaining CGMP compliance preferred

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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level