Johnson & Johnson · 2 days ago

Analyst I, Quality Control - Stability Lab

Raritan, NJ

Full-time

Onsite

Entry Level

$50K/yr - $90K/yr

1+ years exp

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Health CareMedical Device

Comp. & Benefits

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Responsibilities

Conduct general analytical testing of stability samples submitted to the QC laboratories on an as-needed basis.

Review/approve QC laboratory data for validity and accuracy according to cGMP/cGLP standards as needed.

Review statistical analysis, data trending, and reporting.

Contribute to improvements or support quality & compliance and/or process improvement projects related to Stability Operations.

Responsible for initiating Quality Issues for OOS / OOT stability issues, engaging with J&J Lead Statistical SMEs for statistical support of lab investigations and test plans, where required.

Complete and approve corrective and preventative actions (CAPA) as assigned, as well as independently execute and lead change control process.

Participate in internal / external audits and interact with Health Authorities during inspections and lead in discussions demonstrating a proficiency of lab systems, products, and technologies.

Qualification

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Medical DeviceBiopharmaceuticalPharmaceutical IndustryCGMP ComplianceQC LaboratoryCompendial RequirementsTechnical WritingMicrosoft OfficeOutlookExcelWordPowerPoint CommunicationCross-functional CollaborationCGMPCGLPUPLCHPLCDissolutionTOCPH metersELIMSSOPsWork instructionsTMDProtocol/Validation reportsProcess Excellence toolsMethodologies