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Greiner Bio-One Americas

In Process Quality Team Lead

Greiner Bio-One Americas, Monroe, North Carolina, us, 28111

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Greiner Bio-One Americas Responsibility

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The IPQ Team Lead is responsible for overseeing the daily monitoring and inspection of product during manufacturing. The IPQ Team Lead works under the guidance of the IPQ Supervisor and IPQ Manager and is responsible for ensuring compliance with Quality Management Systems policies and procedures, regulatory standards, and inspection of GBO NA products. The role will be assigned to a 2-2-3 Twelve Hour Shift Schedule. Your challenge

Responsibility

The IPQ Team Lead is responsible for overseeing the daily monitoring and inspection of product during manufacturing. The IPQ Team Lead works under the guidance of the IPQ Supervisor and IPQ Manager and is responsible for ensuring compliance with Quality Management Systems policies and procedures, regulatory standards, and inspection of GBO NA products. The role will be assigned to a 2-2-3 Twelve Hour Shift Schedule.

Responsibilities Include

Oversight of IPQ team performance with escalations to the IPQ Supervisor. Directly responsible for mentoring and training IPQ Inspectors. Coordinating daily operational activities to meet departmental Safety, People, Quality, Responsiveness, and Cost KPI’s. Coordinating and performing IPQ inspection and release semi-finished and finished goods inspections according to valid procedure(s). This includes injection molding and final assembly departments. Providing direct oversight for the identification and handling of nonconforming product according to valid procedure(s). Performing timely compliance review and closure of production batch records. Accurately documenting and submitting IPQ and Production Batch records following Good Manufacturing Practice (GMP). Performing timely measurement and reporting for Quality Assurance and Engineering validation activities including IQ, OQ, PQ, Product Verifications, Engineering Studies, Measurement Requests, etc. Supporting maintenance of testing equipment including troubleshooting, scheduling, and/or the performance of internal/external calibrations as required. Performing periodic cycle counting and ordering of IPQ supplies as needed. Performing other administrative duties to ensure IPQ operational readiness as required.

Authority Includes

The direct monitoring and reporting of employee compliance in accordance to GBO NA Safety, Quality, HR, and payroll policies with management escalation to the IPQ Supervisor and Manager. The evaluation of products, control of non-conforming products, and IPQ release according to valid procedures. Responsible for ERP transactions such as stock transfers, quality hold and releases (SAP). Responsible for reporting and troubleshooting inspection devices/equipment and Laboratory Information Management System (Babtec).

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Job Requirements

The following criteria are considered minimums for the role:

High School diploma or GED; Associate’s Degree in Science, life sciences, or related field preferred 5 years of experience in an ISO 9001, ISO 13485, or similar regulated manufacturing environment 3 years of direct Quality Control experience Intermediate-level experience with laboratory testing equipment, instrumentation, and analysis, as well as laboratory data processing and review Intermediate-level MS office skills Intermediate-level knowledge of statistics, calculations, and reporting

Physical Requirements

Must be able to stand and walk for up to 8-12 hours Must be able to lift up to 50 lbs Must have appropriate vision to perform detailed quality inspections as outlined in SOP’s or TP’s Seniority level

Seniority levelMid-Senior level Employment type

Employment typePart-time Job function

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