Job Description

Are you an experienced Technical Documentation Specialist with a desire to excel? If so, then Talent Software Services may have the job for you! Our client is seeking an experienced Technical Documentation Specialist to work at their company in Greensboro, NC.

Position Summary: We are seeking a dedicated and detail-oriented individual to join our team as a Technical Documentation Specialist. This role involves managing and organising documentation within our engineering and process technologies division. The ideal candidate will possess strong leadership skills, a willingness to embrace change, and the ability to collaborate effectively with various teams.

Primary Responsibilities/Accountabilities :

• Organising an archiving system
• Labelling, sorting, and categorising documents for ease of use
• Retrieving documents upon request
• Outlining a long-term storage strategy
• Adhering to regulatory requirements
• Working with colleagues to ensure consistency of documentation practice across the company
• Assisting with both internal and external audits
• Ensuring documentation integrity
• Controlling access to documents
• Removing documents that are obsolete
• Utilising storage software and applications for electronic filing
• Performing transcription and conversion work
• Proofreading documents upon request

Qualifications:

• Execute with Excellence: Experience in Initiative Leadership, Project Management, Marketing Specialist, or Work Process Ownership. Ability to manage multiple projects and priorities with attention to detail.
• Lead with Courage: Demonstrated leadership skills to set direction, hold others accountable, and manage expectations across business functions.
• Embraces Change: Open and adaptable to change, accepting new ideas and work processes.
• Excellent Communication/Collaboration: Strong skills in leading meetings, listening to feedback, and collaborating with internal and external partners.
• Strong Problem-solving: Ability to quickly identify and resolve issues, assess risks, and determine next steps.
• Champion Productivity: Proficiency in analyzing data for reporting, gap analysis, loss analysis, and work process improvement. Mastery of 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

Preferred:

• Previous experience in Enovia and Veeva systems is highly desired

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