Demo

Qualification Documentation Specialist

Orion Talent
Raleigh, NC Full Time
POSTED ON 1/15/2025
AVAILABLE BEFORE 3/20/2025

Description

Independent project work and follow schedule / prioritize work accordingly.

Create Re-Qualification test protocols / templates and complete / archive test documentation.

Sub-project management for the departments of system conformity testing and qualification.

Creation of project-specific test documentation based on applicable standards and guidelines as well as technical installation and functional specifications.

Coordination, cross-checking and technical assessment of test protocols.

Technical assessment of test plans and test reports for compliance with applicable regulations and correct execution.

Multitask with a high level of attention to detail / coordinate qualification strategy with customers.

Completion and archiving of test documentation.

Support of field engineering with qualification questions and interdisciplinary interface function.

Maintenance of process and system data to determine quality.

M1 PM and PURE IQ OQ, PM documentation creation and review.

Requirements :

Bachelor’s degree in mechanical engineering, pharmaceutical technology, chemical engineering or experienced technician

Reading and understanding diagrams, (electrical, pneumatic, P&I diagrams).

Structured and analytical way of working and experience in quality management.

Excellent communication verbal / written communication and proficiency using MS Office products.

Job Posting

Please or to apply.

Salary : $75,000 - $85,000

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