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Technical Documentation Specialist (Greensboro)

Technical Documentation Specialist (Greensboro)

BelcanGreensboro, NC, US
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Job Title : Technical Documentation Specialist (Engineering-Process Technologies )

Location : Greensboro, NC

Zip Code : 27409

Duration : 2 Months

Responsibilities :

  • Organizing an archiving system.
  • Labelling, 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.

Nice To Have :

  • 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.
  • 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.
  • Embraces Change - Is open and flexible / adaptable to change by seeking out and readily accepting new ideas, experiences, skills, opportunities, and new work processes.
  • 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.
  • Strong Problem-solving skills to quickly identify and resolve issues to root cause, access risk and determine approach / next steps to mitigate.
  • 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.
  • Authoring and editing / revising Validation Documents (Protocols, Reports, etc.) for Validation Activities (EOs, PPQs, etc.).

    • Must Have :

  • Authoring and editing / revising Validation Documents (Protocols, Reports, etc.) for Validation Activities (EOs, PPQs, etc.). Experience in cGMP documentation review required Experience in highly regulatory business with ANDA and regulatory requirements Facilitating Review & Approval of Validation Documents in formal Document Management Systems.
  • On-site support to execute Validation Activities in the packaging operations at the GBO PHC plant.
  • Reviewing and providing mark-up / input on Validation Documents authored by others.
  • 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
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    Documentation Specialist • Greensboro, NC, US