QA Specialist - Deviation & CAPA Lead (Onsite Bothell)

TechDigital Group; Bothell (WA); On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Assurance Specialist to enhance cGMP quality operations at their Bothell facility. This role is pivotal in managing deviations, conducting investigations, and ensuring compliance with regulatory standards. The ideal candidate will possess strong communication skills and a proactive approach to quality assurance. You will work closely with cross-functional teams to drive improvements and support product releases, making a significant impact on both clinical and commercial operations. Join a dynamic team that values quality and continuous improvement in a fast-paced environment, where your contributions will be crucial to success.

Qualifications

• 3-5 years experience in quality management systems and deviation oversight.
• Strong communication skills and ability to work cross-functionally.

Responsibilities

• Manage deviations to achieve right first time and on-time phase completion.
• Lead investigations and ensure compliance with GMP standards.

Skills

Deviation Management

Written Communication

Verbal Communication

Cross-Functional Collaboration

Root Cause Analysis

Attention to Detail

Quality Assurance Processes

Time Management

Education

Bachelor's degree in relevant science or engineering discipline

Associate's degree

Tools

Word

Excel

Electronic Quality Record Management System

Job description

An established industry player is seeking a Quality Assurance Specialist to enhance cGMP quality operations at their Bothell facility. This role is pivotal in managing deviations, conducting investigations, and ensuring compliance with regulatory standards. The ideal candidate will possess strong communication skills and a proactive approach to quality assurance. You will work closely with cross-functional teams to drive improvements and support product releases, making a significant impact on both clinical and commercial operations. Join a dynamic team that values quality and continuous improvement in a fast-paced environment, where your contributions will be crucial to success.