Job Information
Granules Pharmaceuticals, Inc Director, Quality Control in Chantilly, Virginia
Direct and manage 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; 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 analytical chemical testing results, adherence to company protocols, and timely 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. Supervise 4 QC Managers. Must have a Bachelors Degree in Chemistry, Biochemistry, Pharmaceutical Science, or Physical Chemistry plus 5 years experience in job offered. Require skills and knowledge in QC Validations, OOT, cGMP/ICH, STPs, SOPs, HPLC-UV, GC, IQ/OQ/PQ. This position is eligible for employee referral program. Submit rsum referencing job code SEE001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.