Quality Assurance Specialist (1st Shift) jobs in United States
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NorthStar Medical Radioisotopes, LLC · 23 hours ago

Quality Assurance Specialist (1st Shift)

NorthStar Medical Radioisotopes is a leading radiopharmaceutical company focused on advancing patient care through innovative therapeutic radioisotopes. The Quality Assurance Specialist will be responsible for reviewing and approving manufacturing documents, assessing non-conformances, and supporting quality systems across departments.

Health CareHealth DiagnosticsHospitalityManufacturingPharmaceuticalTherapeutics
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Responsibilities

Review and approve documents in support of manufacturing and quality testing including batch records, test data, and receiving inspection
Review and assess non-conformances; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
Review, approve and facilitate change controls including tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness
Support remediation efforts to negative quality trends
Interact with all departments to effectively implement and maintain Quality Systems

Qualification

GMP experienceQuality SystemsRisk assessmentsRoot cause analysisPharmaceutical manufacturingBachelor's Degree21CFR regulationsCommunicationTeam collaboration

Required

Bachelor's Degree in Chemistry, Biology, or other related scientific discipline
Minimum two (2) years GMP related experience in biopharmaceutical/pharmaceutical or related industry with direct Quality experience
Familiarity with pharmaceutical manufacturing processes, 21CFR210/211/820/11

Benefits

Competitive benefits package

Company

NorthStar Medical Radioisotopes, LLC

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At NorthStar Medical Radioisotopes, our mission is to provide patients global access to game-changing radiopharmaceuticals.

Funding

Current Stage
Growth Stage
Total Funding
$117.47M
Key Investors
National Nuclear Security AdministrationOberland CapitalStateline Angels
2021-08-30Grant· $37M
2019-04-23Series Unknown· $75M
2015-09-15Series Unknown· $0.27M

Leadership Team

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Frank Scholz
President & CEO
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Paul Estrem
Chief Financial Officer
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Company data provided by crunchbase