Technical Documentation Specialist

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Technical Documentation Specialist (Engineering-Process Technologies)

Job Summary: Talent Software Services is in search of a Technical Documentation Specialist for a contract position in Greensboro, NC. The opportunity will be three months with a strong chance for a long-term extension.

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
  
  

If this job is a match for your background, we would be honoured to receive your application!

Providing consulting opportunities to TALENTed people since 1987, we offer a host of opportunities, including contract, contract to hire, and permanent placement. Let's talk!