Senior Quality Assurance Document Specialist

Essential Areas of Responsibility

• Administers Document Management Program and provides support to end users for the creation, revision, and retirement of documents including: Reviews GxP documents and records for completeness and compliance with internal procedures and applicable regulations and ensures ALCOA++ principles are followed to ensure data robustness.
• Supports and manages document lifecycle in the Electronic Quality Management System (eQMS)
• Maintains and improves Document Management Program procedures
• Provides training on the Document Management Program
• Acts as Administrator for Document Management within the eQMS
• Manages physical document archival and retention program
• Manages the Training Management Program and provides support to end users for the maintenance of training activities including: Maintains user roles, training curricula, and training assignments.
• Maintains and improves Training Management Program procedures
• Provides training on the Training Management Program, as well as Employee Onboarding Program related policies and procedures.
• Acts as Administrator for Training Management within the eQMS

Additional duties to include:

• Inspection readiness and execution tasks, as assigned
• Internal audit support
• Deviation, CAPA, Change Control, and Supplier Qualification support
• Preparation of Quality Management System metrics
• eQMS, design and validation support
• Continuous Improvement initiatives

Education, Experience and Skill Requirements

• Education: BS/BA in a scientific or engineering discipline with 6+ years of experience in pharmaceutical/ biotech industry within Quality Assurance or Quality (Assurance) exposure, or equivalent experiences
• Or, Associate’s degree in a scientific or engineering discipline with 8+ years of Quality experience or Quality (Assurance) exposure or equivalent experiences
• Experience: Knowledge in 21 CFR Part 11, Annex 11, CFR 210, CFR 211, GxP practices
• Knowledge of current regulatory and industry guidelines
• Exposure to global health agency regulations
• Internal audit/self-inspection experience
• Experience in electronic Quality Management Systems
• Proficient in Microsoft Office suite (Word, Excel, PowerPoint, Outlook, and Teams)
• Familiar with SmartSheet and SharePoint platforms
• Excellent written and oral communication skills
• Strong organizational skills with the ability to effectively prioritize and manage multiple projects and tasks with attention to detail in a rapidly changing environment
• Ability to proactively resolve issues in a diplomatic, flexible, and constructive manner
• Highly motivated, ethical individual with excellent time management skills
• Skilled at building consensus, securing stakeholder buy-in, and advancing strategic priorities in a matrixed organization
• Must be authorized to work in US.