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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:
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!
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
- 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.
- Leadership
- Embraces Change/Agile
- Collaborative
- Develops Others
- Operates with Discipline
- Business Mastery
- Technical Mastery
- 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
- Previous experience in Enovia and Veeva systems is highly desired
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!