"Alerted.org

Duration:** **10** **months contract

**Schedule: F** ully Remote. Regular working hours.

Job Description:

We are seeking a Quality Specialist to support client’s 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 our **digital quality systems—such as batch release, quality workflows, and integrated data solutions—**are compliant, reliable, and successfully adopted by global users.

Key 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.

Required Skills & Competencies

+ 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.

Must Have skills:

+ Looking for someone with PM experience and quality background

+ This position will largely be focused on validation testing, writing, change management responsibilities and some PM work.

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"