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Evergen · 3 days ago

Senior Quality Technician

Alachua, FL

Full-time

Onsite

Senior Level

$27/hr - $30/hr

6+ years exp

Evergen is a global industry-leading contract development and manufacturing organization in regenerative medicine. The Senior Quality Technician will provide support for Quality Engineering functions, lead investigations for nonconformance issues, and participate in validation activities to ensure product quality and compliance.

Health CareIndustrial ManufacturingMedical DeviceProduct Design

Responsibilities

Provides support for Quality Engineering functions such as manufacturing, sterility assurance, or supplier quality and may lead projects and improvement initiatives

Leads investigations for product or supplier nonconformance and process noncompliance issues and documents exceptions appropriately in the Corrective Action / Preventative Action (CAPA) System

Performs CAPA activities inclusive of root cause analysis, investigations, product and process disposition, and effectiveness check with a high attention to detail

Participates in the review and disposition of non-conforming product or controlled process inputs including the Product Quality Review Board (PQRB), returns, and complaints

Supports validation activities inclusive of reviewing and approving data sheets, drafting of validation protocols, and documenting the results in a validation report

Performs process and safety audits and documents the results appropriately

Assists in Change Management function including maintaining relevant Work Instructions, Standard Operating Procedures, and other documentation

Performs product acceptance testing, quality inspections, data entry, and data corrections quickly and accurately

May provide support for environmental monitoring investigations, documentation of quality inspections on controlled suppliers, or supports the Approved Supplier List monitoring activities

Identifies and supports process improvement initiatives and implementation

May support projects as a quality resource as assigned

May mentor or train other team members

Qualification

Quality AssuranceMicrobiologyASQ CertificationTechnical WritingMicrosoft Office SuiteInvestigationsProblem-solvingVerbal CommunicationWritten Communication