Summary of Key Responsibilities: Author or act as reviewer for lab investigations, deviations, protocols and specifications for raw materials an dfinished products. Schedule the QC laboratory workload appropriately to meet customer release testing schedules, stability pull dates and timelines. Monitor weekly laboratory and data review activities for accuracy and track hours needed for completion of tasks. Oversight for review of QC and Stability data for compliance with Customer Requirements and specifications and regulatory requirements Interact with third party laboratories for microbial and analytical testing of finished products and raw materials Generate and/or review shipping paperwork for third part testing and prepare samples for shipment. Create purchase requisitions for lab supplies and third-party testing Perform weekly laboratory audit inspections Perform sampling of raw materials Assist with implementation of the Raman hand-held spectrophotometer for ID testing. Review third party laboratory investigations and protocols. Provide technical support to the laboratory for method troubleshooting as needed. Qualifications: B.S. in a scientific discipline. 5 years’ experience in a Quality Control/Assurance role in the pharmaceutical industry. Experience with USP, EP and JP monographs. Experience lab applications such as Empower CDS, (UV Spectral, Ion detectors), FTIR, and Particle size Mastersizer. Experience with Power BI is a plus Experience in Data Review of Analytical data per GDP guidelines. Proven ability to review and evaluate the compliance and completeness of analytical data. Thorough knowledge of GxP regulations. Proven ability to collaborate with technical staff and customers. Is thorough when performing work; conscientious about attention to detail; uses logical thinking that is well organized and methodical. Able to multi-task productively, applying time management processes and procedures effectively. Technically capable of determining what is wrong in complex situations and offering potential solutions, identifying root cause of a problem, and working with others to correct problems. Works toward common goals by supporting, encouraging, and sharing information with colleagues. Speaks, writes, listens, and presents information in a logical and articulate manner.