Jobs via Dice · 8 hours ago
Quality Assurance Specialist
United States
Full-time
Remote
Senior Level
$55.78/hr - $55.78/hr
5+ years expApTask Global Workforce (AGW) is seeking a Quality Assurance Specialist with a biotechnology company. The role involves supporting digital quality transformation, leading validation testing, and managing cross-functional projects across digital Quality platforms.
Computer Software
Responsibilities
Support digital quality transformation by leading validation testing, driving change management, and managing cross-functional projects across digital Quality platforms
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
Qualification
Required
Bachelor's degree and 5 years of experience OR Master's degree and 3 years of experience OR Associate's 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
Experience in a project management and quality background
Excellent communication skills and ability to work effectively in a matrixed, cross-functional environment
Exceptional attention to detail, analytical mindset, and ability to manage competing priorities
Preferred
5+ years of biopharmaceutical experience in Quality, Validation, Manufacturing, Regulatory, or related areas
Knowledge of GMP regulations, digital quality systems, and modern quality technologies
Bilingual in English and Spanish
Benefits
Medical
Dental
Vision
Sick Pay (for applicable states/municipalities)
Company
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0-1 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase