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

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