Technical Writer

• • 1. Execute with Excellence - Previous role experience within Initiative Leadership, Project Management, Marketing Specialist, or Work Process Ownership. Demonstration and Implementation of work processes, workflows, working with Multifunctional Resources/Teams. Acts as a business owner with great sense of urgency and focus to manage multiple projects/priorities with the organization and attention to detail. High Capacity to lead multiple projects at any given period. 2. Lead with Courage – Ability to demonstrate Leadership to set direction/priority for others, hold others accountable to deadlines, develop execution plans, and work collectively across functions and suppliers. Can manage expectations and engagement across all business functions. 3. Embraces Change – Is open and flexible/adaptable to change by seeking out and readily accepting new ideas, experiences, skills, opportunities, and new work processes. 4. Excellent Communications/Collaboration skills to lead meetings, listening to feedback/input to put into clear actions, written updates to Initiative teams/leadership, peers and escalate help requests/issues. Strong Collaboration with internal and external partners. 5. Strong Problem-solving skills to quickly identify and resolve issues to root cause, access risk and determine approach/next steps to mitigate. 6. Champion Productivity- Demonstration of skills/experience to analyze data for utilization in results reporting (written/oral), gap analysis, loss analysis and work process improvement. Is capable to demonstrate mastery within Microsoft Word, Excel, Powerpoint and Office 365 Tools. Skills Needed: Leadership, Embraces Change/Agile, Collaborative, Develops Others, Operates with Discipline, Business Mastery, Technical Mastery.
• Accurate documentation skills
• • GMP (Good Manufacturing Practices) Compliance • GDP (Good Documentation Practices) • QMS (Quality Management Systems) • FDA 21 CFR Part 210, 211, 820 Regulations • Batch Record Review & Approval • CAPA (Corrective and Preventive Actions) • Investigation & Deviation Management • Change Control Management • Quality Systems Auditing (Internal/External) • Pre-Approval Inspection (PAI) Preparedness • Aseptic Processing & Sterile Drug Products • Document Control & SOP Review • Training Program Development & Delivery • On-the-Job Training (OJT) & Curriculum Development • Regulatory Compliance & Inspection Readiness • Data Integrity & LIMS • Root Cause Analysis & Problem Solving • Customer Complaint Investigation • Project Management & Continuous Improvement • TrackWise, Veeva Vault, Documentum, QUMAS • MS Visio, MS PowerPoint, Excel, Word, Smartsheet

Nice To Have