SGS · 4 days ago

Specialist I, Quality Control

Fairfield, NJ

Full-time

Onsite

Entry Level

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Responsibilities

Perform special project data review following staff performance of customer test requests in a timely and effective manner. Customer test requests include wet chemistry, instrumentation, and/or microbiological data reviews

Perform reviews for reagent and standard preparations and their assays or suitability testing and/or media preparation and associated media checks

Perform equipment performance logs reviews, auxiliary log book reviews, stability study pull reviews, audit trail reviews, and metrology reviews

Perform Out of Specification (OOS) and Method Validation Failure (MVF) wet chemistry and/or microbiology investigations following staff performance of customer test requests in a timely and effective manner

Ensure that all testing submitted by customers is completed within established parameters governing Company quality and regulatory compliance specifications

Ensure that all reasonable requests from Department Management on the review of laboratory data supporting a given test or group of tests are met in a timely and effective manner

Play a role in Departmental or company-wide projects designed to improve the internal efficiency and overall quality of work performed at the laboratory

Participate in creating and maintaining an atmosphere of teamwork throughout the laboratory

Maintain thorough knowledge and understanding of all Standard Operating Procedures (SOPs) of the review process

Maintain thorough knowledge and understanding of GMP/GLP/ISO requirements as these pertain to work performed in the laboratory

May be invited to participate in the preparation and review process for appropriate department SOPs, worksheets, and data forms

Participation in general staff training sessions as is scheduled

Qualification

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Scientific Principles