What are the responsibilities and job description for the Quality Assurance Specialist (Pharma GMP) position at Integrated Resources, Inc ( IRI )?
Position Summary
The Research Quality Operations Document Manager oversees the maintenance of a controlled documentation system to ensure compliance with regulatory standards and corporate policies. This role involves technical writing and editing for various documents within a modern software development environment. Responsibilities include tracking and reviewing change control documentation, as well as assisting in the editing of quality documents such as Standard Operating Procedures (SOPs), guidelines, policies, and work instructions. The ability to work swiftly while upholding high accuracy is essential.
The ideal candidate should possess strong interpersonal and information-gathering skills, enabling effective communication with individuals at all levels within the organization. The candidate should be adept at working both independently and within a team, demonstrating the ability to interact effectively with others. Additionally, responsibilities include reviewing current documents, incorporating feedback from project leaders and subject matter experts (SMEs), navigating the Veeva Document Management System (Veeva) using existing templates, and communicating workflow status and issues to project leaders or SMEs.
Principal Responsibilities
• You will be responsible for designing, developing, and updating change control documentation.
• Performing technical writing and editing for all types of documentation in the Veeva Document Management System.
• Tracking and reviewing change control documentation and assisting with the editing of quality documents such as SOPs, guidelines, instructions, etc., to ensure compliance with regulatory requirements.
• Reviewing current documents and incorporating comments from project leaders and other SMEs.
• Navigating through the Veeva Document Management System and using current templates.
• Notifying document authors and business owners about the workflow status and issues.
Qualifications
• Must possess sound interpersonal and information-gathering skills, enabling you to relate well to others at all levels throughout the organization
• Proficient in technical writing abilities and strong time management
• Strong root cause analysis skills with experience in quality standards
• Ability to establish working relationships with support areas to gather necessary information
• Proficient in Veeva Document Management System with proven experience in using templates, as well as knowledge of Veeva workflows, and approval processes.
• Proficient in MS Word, Excel, PowerPoint, and Outlook
• Self-motivated with a proactive approach to resolving issues
• Excellent verbal and written communication skills
• Ability to work effectively in a team environment and independently
Education
• College or university graduate preferred.
• Secondary Education diploma is a requirement.
