Technical Documentation Specialist
8 hours ago
Technical Documentation Specialist in Greensboro NC
Duration: 3 months contract with possible extension
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.-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.-Utilizing storage software and applications for electronic filing.-Performing transcription and conversion work.-Proofreading documents upon request.
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.
Must have:
- 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
Meet Your Recruiter
Vishwas BM
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