Specialist I, Quality Control

Job Description
Specialist I, Quality Control is responsible for the second person review of selected data generated in the laboratory. The Quality Control Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This position presents the employee with an opportunity to contribute first-hand to the process of providing quality data to the SGS customer base.
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