Quality Assurance Specialist

4 days ago


Bothell, Washington, United States Omni Inclusive Full time
Job Overview

In this role at Omni Inclusive, you will play a key part in ensuring the quality of our products. As a Quality Assurance Specialist, your primary responsibility will be to lead and facilitate deviation triages, investigations, and approvals within our quality management system.

About the Job

This position requires a highly organized individual with excellent communication skills and a proven track record in managing deviations and CAPA. You will work closely with cross-functional teams to drive on-time phase completion and ensure compliance with regulatory requirements.

We are seeking an experienced professional with 5-8 years of experience in oversight and execution of deviation initiation, investigations, and approvals. A Bachelor's degree in a relevant science or engineering discipline is preferred, but not required.

You will be responsible for:

  • Leading/facilitating triages, deviation process, investigations (as applicable), and No Impact deviation closure of records, CAPA (Corrective and Preventative Action), change controls, process transfers, and other business drivers in a compliant manner.
  • Participating in cross-functional project teams to drive on-time phase completion, including No Impact deviation closures, RCA Assessment approvals.
  • Maintaining and routinely communicating an up-to-date dashboard of department-specific CAPA to show status, escalate issues, provide mitigation plans, and request additional support.
Key Skills and Qualifications

To be successful in this role, you will need:

  • Excellent written and verbal communication skills.
  • Proven experience in oversight and execution of deviation initiation, investigations, and approvals within a quality management system.
  • Experience in cGMPs and FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
  • Able to work independently and as part of a team.
  • Strong analytical and problem-solving skills.
  • Ability to anticipate and mitigate challenges.

The estimated salary for this role is $95,000 - $115,000 per year, depending on experience and qualifications.



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