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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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Specialist, Quality Assurance
Remote, CA US
Posted: 02/18/2026
2026-02-18
2026-03-20
Employment Type:
Contract
Job Category: Quality
Job Number: 4889
Job Description
Our client is seeking a Quality Specialist to support the digital quality transformation by leading validation testing, driving change management, and managing cross-functional projects across our digital Quality platforms. This role ensures that enhancements to digital quality systems—such as batch release, quality workflows, and integrated data solutions—are compliant, reliable, and successfully adopted by global users.
Responsibilities:
Responsibilities:
- Lead validation activities for digital quality system updates, including test planning, execution, documentation, and issue resolution.
- Drive change management to support new system capabilities, user adoption, communications, and training.
- Manage multiple digital quality projects involving system enhancements, process improvements, and cross-functional coordination.
- Ensure digital workflows and integrations supporting material and product release meet GxP requirements.
- Collaborate with internal partners and external vendors to ensure timely, compliant, and high-quality delivery.
- Doctorate degree OR Master degree and 3 years of experience OR Bachelor degree and 5 years of experience OR Associate degree and 10 years of experience OR High school diploma / GED and 12 years of experience
- Strong GxP background with direct experience in material and product release.
- Hands-on experience with digital quality systems (e.g., eQMS, complaint systems, digital batch release, quality data integrations).
- Proven capabilities in validation testing, change management, and project leadership.
- Excellent communication skills (English & Spanish preferred) and ability to work effectively in a matrixed, cross-functional environment.
- Exceptional attention to detail, analytical mindset, and ability to manage competing priorities.
- Preferred Qualifications
- 5+ years of biopharmaceutical experience in Quality, Validation, Manufacturing, Regulatory, or related areas.
- Knowledge of GMP regulations, digital quality systems, and modern quality technologies.