Senior Document Control & Change-Order Lead (2-Month Contract)

Select Source International; California; Sur place; USD 40 000 - 54 000; Temps partiel

Résumé du poste

Select Source International in San Diego, CA seeks an experienced Senior Document Control Specialist for a 2-month contract. You will coordinate change orders, manage document control and deviations, and ensure compliance with 21 CFR 820 and ISO 13485 standards.

Responsibilities include issuing document numbers, maintaining SOPs, training staff, and supporting audits. This role requires strong technical writing skills and knowledge of electronic document management systems.

Qualifications

• Bachelor's Degree or equivalent experience in quality/compliance.
• 2+ years in QA or document control in regulated industry.
• Knowledge of 21 CFR 820 and ISO 13485:2016.
• Experience with electronic document management systems.
• Experience with technical writing and SOPs.
• Agile DMS experience preferred.

Responsabilités

• Serve as Change Order Coordinator for the facility.
• Manage document change orders and deviations from review to release.
• Ensure documents comply with GxP and company procedures.
• Issue document numbers and manage archiving and obsolescence.
• Provide document control training and QA-related materials.
• Support internal and external audits.
• Contribute to continuous improvement of the QMS.

Connaissances

Quality Assurance

Document Control

Technical Writing

SOP drafting

Audit readiness

Formation

Bachelor's Degree

Equivalent combination of education and experience

Outils

Agile Document Management System

Description du poste

Select Source International in San Diego, CA seeks an experienced Senior Document Control Specialist for a 2-month contract. You will coordinate change orders, manage document control and deviations, and ensure compliance with 21 CFR 820 and ISO 13485 standards.

Responsibilities include issuing document numbers, maintaining SOPs, training staff, and supporting audits. This role requires strong technical writing skills and knowledge of electronic document management systems.