Specialist qc stability and raw materials

Overview
Job Summary (Primary function)The QC Specialist Stability and Raw Materials is responsible for the operational activities related to Stability testing and Raw Materials (RM) testing & release at Incyte QC Bioplant.
This includes (but is not limited to) the planification, the definition of the analyses to be carried out, the samples shipment for outsourced testing, the execution of analytical testing upon request, the internal & external results/data review and their approval within the defined lead time.
The QC Specialist QC Specialist Stability and Raw Materials is the point of contact for Quality Assurance, Manufacturing, Supply Chain, Warehouse, other Quality Control teams and External Laboratories.
The QC Specialist QC Specialist Stability and Raw Materials owns the deviations, CAPA and change controls for the QC activities under his/her responsibilities.
Essential Functions of the Job (

Key responsibilities
)Plan and coordinate Raw Materials (RM) lab activities of the team of ordinate the design, initiation, and execution of stability studies according to ICH and regulatory llaborate with QC analysts and laboratory supervisors to ensure timely completion of testingAct as the primary point of contact for stability-related queries across QC, QA, Manufacturing, Regulatory Affairs, and Supply Chain.
Support regulatory submissions by providing stability data and summaries.
Participate in cross-functional meetings to provide updates on ongoing stability studies and timelinesAccountable for the on-time execution of stability programs. Accountable for Stability reporting,Execute data review for Stability and RM for internal and external testing.
Author, review, and maintain Standard Operating Procedures, Work Instructions, and all other quality documents related to areas of responsibility, as well as support other areas as required.
Define the appropriate test of RM specifications in compliance with reference documents (USP, Eur. Ph., JP, BLA, and beyond)Contribute to the introduction of new products at Bio Plant: be the point of contact and manage the interface between Analytical