The QC Microbiology Data Reviewer II is responsible for the review of data generated in the laboratory and to assist Operations Management in the conduct of investigations and other specialized reviews and reports. In addition, the Quality Control Specialist must be sensitive to the demanding regulatory compliance requirements attending to the operation of a pharmaceutical testing laboratory. This job also requires the ability to demonstrate a high commitment to interpersonal relations.
- 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 logbook 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