Quality Assurance Associate

Quality Assurance AssociateRecommend SOP and batch record changes as neededReview proposed SOP revisions and provide feedback to managementReal-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parametersPerform room and equipment clearances per procedure following cleaning conducted by productionPerform microbial swabbing of equipment and room surfaces for environmental monitoringMaintain a full understanding of all client's SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical productsPerform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-timeMonitor production manufacturing areas for compliance to SOP/cGMP/batch record and safety requirements in order to identify and resolve routine errors and prevent possible deviations that affect production real-timeWorks cross functionally to assess impact for potential deviations and assist in identifying if an investigation is requiredInitiate deviation problem reports in Trackwise for issues discovered by QA, providing sufficient detail of the incident so that a full investigation by the responsible department can be conductedManage quality status of WIP and finished good materials on physical inventory and in inventory system (JD Edwards)Other assignments as needed within the scope of QA Associate training curriculumAssist in investigations for deviations by supporting data gathering and root cause analysisEnforcement of GMP CompliancePromotes teamwork and good communicationProvide training and coaching to manufacturing staff as neededSupport site process improvements (training, efficiency projects, implementation of CAPAs)Completes investigations of customer complaintsMinimum education and experience required to perform the job:Quality Assurance AssociateBachelors degree; ORAssociates with 1 year of related work experience; ORHigh School Diploma/GED with 2 years of related work experience LanceSoft