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Talent Software Services, Inc

Technical Documentation Specialist

Talent Software Services, Inc, Greensboro, North Carolina, us, 27497

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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!

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