Quality Control Specialist jobs in United States
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NorthStar Medical Radioisotopes, LLC · 11 hours ago

Quality Control Specialist

NorthStar Medical Radioisotopes is a leading company in the radiopharmaceutical industry focused on improving patient care through innovative technologies. The Quality Control Specialist will operate analytical instrumentation, ensure compliance with quality standards, and participate in various quality assurance activities to support the manufacturing of radiopharmaceuticals.

Health CareHealth DiagnosticsHospitalityManufacturingPharmaceuticalTherapeutics
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Responsibilities

Operate analytical instrumentation
Author and revise documents in the eQMS system
Train others on methods, procedures and techniques as required
Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys
Perform and review receiving inspection tasks for release in the ERP system
Perform environmental monitoring in accordance with all applicable standards
Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs
Perform technical review of analytical data and lab logbooks
Execute microbiological, chemical, radiochemical, and stability testing
Initiate and approve non-conforming material reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations
Participate in multiple Project Teams and other meetings

Qualification

Analytical instrumentationCGMP environmentRadioactive materials handlingPharmaceutical manufacturing processesBatch production recordsEnvironmental monitoringMicrobiological testingChemical testingRadiochemical testingStability testingTechnical writingTeam collaboration

Required

Bachelor's Degree in Chemistry, Biology, or other related scientific discipline
Minimum three (3) years of experience in a regulated industry (e.g., analytical instrumentation / prior laboratory experience)
Operate analytical instrumentation
Author and revise documents in the eQMS system
Train others on methods, procedures and techniques as required
Safely handle radioactive material, which includes monitoring radioactive dose, sampling, aliquoting, and performing contamination surveys
Perform and review receiving inspection tasks for release in the ERP system
Perform environmental monitoring in accordance with all applicable standards
Participate in DCO collaboration of documents in support of manufacturing and quality testing including test data, protocols, reports, SOPs
Perform technical review of analytical data and lab logbooks
Execute microbiological, chemical, radiochemical, and stability testing
Initiate and approve non-conforming material reports (NCMRs), investigate deviations, laboratory out-of-specification (OOS), and CAPA investigations
Participate in multiple Project Teams and other meetings

Preferred

Four (4) years of related experience in a cGMP environment and previous experience handling radioactive materials
Understanding of pharmaceutical manufacturing processes, and familiarity with batch production records (BPR)
Familiarity with alpha, gamma, and beta spectroscopy

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