Quality Systems Specialist

Overview

Almac Group is seeking a Quality Systems Specialist for our Durham, NC location. The Quality Systems Specialist I will be responsible for ensuring compliance with CLIA / CAP, ISO15189, ISO13485, GCP, GLP and GCLP requirements within Almac Diagnostic Services, and for ensuring that Quality Management System activities are implemented and maintained. This includes document control, KPI reporting, LMS management, hosting audits, maintaining laboratory licenses / accreditations and QMS reviews are adequately planned, performed, and implemented on a continual basis as required by the company\'s quality policy and regulatory agencies.

Responsibilities

• Maintain the Quality Helpdesk and manage document requests in a timely manner.
• Initial triage of incoming documents and quality systems review of documentation.
• Provide feedback to unit SMEs and update KPIs.
• Serve as System SME for the respective business unit and administer Q-Track (LMS).
• Generate Weekly Q-Track KPIs and report trends to team leaders / managers.
• Advise leadership on system updates / improvements and generate weekly SPC charts for discussion.
• Manage Trackwise (LMS) system and reporting; generate reports including KPIs.
• Provide training and maintain laboratory licenses and accreditations globally, including gap analyses against updated standards.
• Review calibration and maintenance data for compliance with approved methods and procedures.
• Ensure all necessary quality records are completed and reviewed / approved by responsible personnel.
• Create, review, and approve policies, procedures, work instructions, protocols, and reports to ensure regulatory compliance (CLIA / CAP, ISO15189, ISO13485, GCP, GLP, GCLP).
• Make recommendations for improvements where appropriate.

Qualifications

Required Experience / Education :

Preferred Experience / Education :

What can Almac Group offer you?

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Almac Group, Inc. is an Equal Opportunity Employer - Minorities / Women / Protected Veterans / Disabled - Proudly embracing diversity in all of its expressions.

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Almac provides reasonable accommodations to people with disabilities who need assistance completing the application process. Please email us at ADARequest@almacgroup.com to request assistance.

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