Aditi Consulting · 13 hours ago
Quality Assurance Specialist
Aditi Consulting is seeking a Quality Assurance Specialist to support their digital quality transformation by leading validation testing and managing cross-functional projects. This role focuses on ensuring that enhancements to digital quality systems are compliant and effectively adopted by global users.
AppsConsultingInformation TechnologySoftware Engineering
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
Qualification
Required
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
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
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
Benefits
Medical
Dental
Vision benefits
10 paid days off
401(k) plan participation
Commuter benefits
Life and disability insurance
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
H1B Sponsorship
Aditi Consulting has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageRecent News
bloomberglaw.com
2025-10-16
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