Specialist Quality Assurance jobs in United States
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Planet Pharma · 12 hours ago

Specialist Quality Assurance

Planet Pharma is a company focused on digital quality transformation, and they are seeking a Quality Specialist to support this initiative. The role involves leading validation testing, managing change, and overseeing cross-functional projects to ensure compliance and effective adoption of digital quality systems.

BiotechnologyHealth CarePharmaceutical
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H1B Sponsor Likelynote

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

GxP backgroundDigital quality systemsValidation testingChange managementGMP regulationsProject leadershipAnalytical mindsetCommunication skillsAttention to detail

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

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

Company

Planet Pharma

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Planet Pharma is a pharmaceuticals company.

H1B Sponsorship

Planet Pharma 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
2022 (3)
2021 (5)
2020 (5)

Funding

Current Stage
Late Stage

Leadership Team

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Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
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Emma Morris
President, PPG Advisory Partners
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Company data provided by crunchbase