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Merck · 1 day ago

Associate Director, Quality Control - (Device Quality & Regulatory)

Rahway, NJ

Full-time

Hybrid

Lead/Staff, Director/Executive

$126K/yr - $199K/yr

5+ years exp

Merck is a leading global healthcare company, and they are seeking an Associate Director, Quality Control to provide QA/QC oversight for their Device Network design verification laboratories. This role involves ensuring compliance with quality standards, supporting audits, and providing leadership and mentorship to personnel.

BiotechnologyHealth CareMedicalPharmaceutical

Comp. & Benefits

No H1B

Responsibilities

Serve as quality oversight for design verification laboratories:

Quality oversight for qualification, maintenance and calibration of laboratory equipment, instrumentation and test methods used to support design verification

Provides quality approval for applicable equipment validation protocols and reports, test method validation protocols and reports, change controls, deviations and CAPA

Ensures procedures used by design verification laboratories align with Good Laboratory Practices, Good Documentation Practices, and applicable regulatory requirements

Provides support for internal audits and regulatory agency audits

Promotes awareness of applicable regulatory requirements and QMS requirements for design verification laboratories

Ensure compliance with data integrity expectations:

Leads implementation of ALCOA+ principles for data generated by the design verification laboratories

Supports establishment of controls for computer system administration, data archival and data retention

Provide strategic direction, mentorship, and development opportunities to personnel

Qualification

Quality Control ManagementRegulatory ComplianceLaboratory Practices (GLPs)Internal AuditingLaboratory Equipment CalibrationValidation ProtocolsLaboratory OperationsMicrobiological AnalysisContinuous Improvement ToolsBiological AnalysisCounterfeit DetectionIdentifying Customer NeedsRegulatory AwarenessSystem AdministrationTechnical TransferQuantitative AssayCommunication SkillsInterpersonal SkillsProper Documentation