Quality Systems Specialist jobs in United States
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Nuvalent, Inc. · 16 hours ago

Quality Systems Specialist

Nuvalent is an early-stage company focused on creating selective medicines for cancer patients. The Quality Systems Specialist will assist with the daily administration of the quality management system and provide technical and compliance support to enhance data integrity and quality culture within the company.

BiotechnologyLife ScienceTherapeutics

Responsibilities

Assist with review of documents under revision, issuance of records, tracking of controlled documents, and management of the Quality Files
Provide assistance to users on the process of writing SOP’s and other documents
Assist with administering GxP implemented quality management systems, assign and track training
Track procedural document record archives for all GxP functions
Track and trend deviations, change controls, CAPA and product complaints to closure
Responsible for delivery of training programs, as well as, prepare and provide training reports
Provide training follow-up reminders and status updates for assigned training
Assist with providing system admin technical support for GxP implemented electronic systems
Assist with the management of Audit Program activities including document management, tracking, notifications, metrics, and reporting
Supports all training activities within the Quality team for the entire company

Qualification

Document ControlQuality Events MonitoringElectronic Quality SystemsELMSElectronic Training SystemsBiologyChemistryLife SciencesCommunication SkillsAttention to Detail

Required

3+ years of experience in the pharmaceutical industry
Experience in Document Control and Quality Events monitoring
Experience with Electronic Quality Systems
Experience with ELMS and Electronic Training Systems

Preferred

Bachelor's degree in biology, chemistry, or a life sciences field is preferred or related experience

Company

Nuvalent, Inc.

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Nuvalent is creating precisely targeted therapies for patients with cancer designed to overcome the limitations of existing therapies for clinically proven kinase targets.

Funding

Current Stage
Public Company
Total Funding
$1.82B
Key Investors
Bain Capital Life SciencesDeerfield
2025-11-18Post Ipo Secondary· $500M
2024-09-16Post Ipo Equity· $575M
2023-10-16Post Ipo Equity· $300M

Leadership Team

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James Porter
CEO
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Alexandra Balcom
Chief Financial Officer
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Company data provided by crunchbase