Technical Documentation Specialist

Description

Hybrid

Must Have

Execute with Excellence –

• 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.

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.

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

• Previous experience in Enovia and Veeva systems highly desired

JOB DESCRIPTION

• Organizing an archiving system.
• Labeling, sorting, and categorizing documents for ease of use.
• Retrieving documents upon request.
• Outlining a long-term storage strategy.
• Adhering to regulatory requirements.