Quality Assurance Manager

Torrey Pines Solutions

+2
+3
California, United States

+2
+3
California, United States

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About the job Quality Assurance Manager Quality Assurance ManagerJob DescriptionGeneral PurposeThe primary responsibility of this position is to oversight GxP activities and maintain the effective quality system within the company. This position will report directly to CEO and work closely with our CMC and Clinical Operations teams to ensure the compliance of relevant regulatory. The duties include but not limited to maintain appropriate document system, review/approve critical documents and perform the audit internally or externally. Main Job Tasks and Responsibilities Responsible for QAU administration.Torrey Pines Solutions is Hiring! We have an immediate need for a Quality Manager. Candidate must have Biotech/Pharma industry GxP experience - No exceptions. Principals only no agencies. For immediate consideration, please contact me at rwilliamson@torreypinessolutions or reviewing required documents for GMP compliance.The maintenance of the document management system.Identify training needs and organize training interventions to meet quality standardsPerform the internal/external audit and finalize the audit report Evaluate audit findings and ensure appropriate corrective as well as preventive actions in place if applicableCooperate with internal team/external parties to investigate customer complaints and non-conformance issuesAnalyze data to identify areas for improvement in the quality systemAdditional duties as required and assignedMust HaveB.S. or M.S. in sciencesPrior experience as a QA AuditorAuditing experience of GMP quality standardsAbility to analyze and sort problems in a logical way with root cause analyses of non-compliance and CAPANice-to-Have Working experience with CMO/CRO/Outsourcing Testing Lab (OTL)Drug substance/product or pharmaceutical industry-specific experienceCertifications an advantage including Quality Auditor, Quality Engineer, Quality Improvement Associate, Six SigmaAuditing experience of GCP quality standardsExperience with implementation of corrective/preventive action programsKnowledge of relevant regulatory requirements (FDA GxP regulations and ICH guidelines)Key Competenciesattention to detailcommunication skills - verbal and writtendata collection, management and analysisproblem analysis and problem solvingplanning and organizingjudgmentdecision-makingteamwork

Wünschenswerte Fähigkeiten

GCP
GxP
Six Sigma

California, United States

Berufserfahrung

QA
QA Test Automation

Sprachkenntnisse

English

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