Spclst, Quality, Bio-Analytical Laboratories
Current-Supplies Inspection and Retention Program Area Owner - Quality Operations Laboratory. Responsible for ensuring both areas meet the company demands in a compliant GMP environment while ensuring the processes are alignment with other Merck sites. Creating a defect library, reporting non-conformances and training incoming personnel. -Deviation Management in the Quality Operations (QO) Laboratories - Under this role, I managed the coordination and investigational writing for the Environmental Monitoring (EM) Laboratory on behalf of all lab employees. The scope later included coordinating all Bio-Analytical Laboratories including the writing of EM Lab QNs and training peers on coordination of investigations in SAP.- Environmental Monitoring Laboratory Specialist - scope included: Bioburden testing; Reading / approving plates; Conductivity/ TOC testing; Coliform testing; Compressed Gas Identity testing and Endotoxin testing. Major accomplishments under this role: Qualified all in-process media bioburden testing for one manufacturing building; Successfully developed the Performance Qualification (PQ) for the VITEK and assisted with the IOQ.- IPT QA Coordinator - Scope included: GMP Auditing of facilities and Mfg. processes (Qualified Auditor); Authoring investigations; Environmental Monitoring for Routine and Per-Process Mfg. activities; Authored Change Controls for LIMS; Authored several Compliance Protocols for the EM Lab and SOP writing.Please reference Resume for more information.
