Overview

Quality Assurance Specialist (Call Center) Jobs in United States at Church Pension Group Services Corporation

Inteldot has over 14 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Job Description:

Under minimal supervision, support Quality Assurance program by performing a variety of key responsibilities in manufacturing, process validation, regulatory compliance, and quality assurance activities. This role requires strong technical expertise, project management skills, and the ability to work cross-functionally in a regulated environment.

Responsibilities:

Review and approve product Master Plans (MPs).
Approve process validation protocols and reports for manufacturing processes.
Participate in Quality on Incident Triage Team.
Approve Environmental Characterization reports.
Release sanitary utility systems.
Approve planned incidents.
Represent QA in the New Product Introduction (NPI) team.
Lead investigations and site audits.
Own and maintain site quality program procedures.
Serve as QA Manager designee on local Change Control Review Board (CCRB).
Review and assess risk evaluations.
Support automation activities, facilities, and environmental programs.
Review and approve Work Orders and EMS/BMS alarms.
Approve non-conformance (NC) investigations and CAPA records.
Approve change controls

Requirements:

Experience in Quality Systems (Deviations, CAPAs, Change Controls) and Equipment, Processes and Facilities Validation
Experience in Quality Systems management and Validation.
Knowledge or to be familiar with in PAS-X/MES application, MAXIMO, SAP, LIMS, QMTS and Veeva.
Available during weekends and holidays as requested

Education & Experience:

Bachelor’s degree & 5 years of related experience

Title: Quality Assurance Specialist (Call Center)

Company: Church Pension Group Services Corporation

Location: United States

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