QC Documentation Specialist

Position Summary

Cross-functional to support relevant Quality Systems GXP activities in adherence to applicable regulations (FDA, EU, etc.) and standards (ICH Q10, ISO). Also supports the implementation and improvement of Quality Systems to ensure quality and adherence with current Good Manufacturing Practice (cGMP) and inspection readiness.

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 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.
• Affords document owners in generating training materials and quiz questions.
• Acts as Administrator for Training Management within the eQMS.
• Assists document owners in generating training materials and quiz questions.
• Acts as Administrator for Training Management within the eQMS.
• 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
• Skills:
• Skilled at building consensus, securing stakeholder buy-in, and advancing strategic priorities in a matrixed organization
• Must be authorized to work in US.
• We are not accepting resumes from agencies.