Director, Quality Control Lab (Chantilly, VA)
Chantilly
Job Description Job Description Description: As a Director, Quality Control (Chantilly, VA) at Granules Pharmceuticals Inc, you wil lbe responsible for Directing and managing all facets of the Quality Control Lab, including samples, reference standards, supply/equipment, QC data trending analysis in compliance with cGMP/ICH and pharmaceutical regulatory compliance; Responsibilities include: Represent QC department during scientific and technical discussions with clients, vendors, and FDA representatives; Build and implement effective laboratory systems, processes, and teams for smooth lab operation using QC Validations; Oversee Quality Control Laboratory to ensure accurate ad tnalytical chemical testing results, adherence to company protocols, animely completion of projects using HPLC-UV, GC, IQ/OQ/PQ, STPs; Interface with different departments regarding quality issues, audits, and special projects; Provide guidance to pharmaceutical manufacturing regarding quality and cGMP issues to ensure compliance with regulatory standards; Review and approve OOS/OOT, SOPs, lab related investigations, stability failure notifications, COAs, and compilation of stability-related data; Review and approve STMs for raw materials, packaging materials, and in process and finished products; Review and authorize certificates of analysis and purchase requisitions