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Director, Quality Control Lab

2 months ago

Chantilly, United States Granules Full time
Job DescriptionJob DescriptionDescription:

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.
  • Supervise 4 QC Managers.
Requirements:

  • Must have a Bachelor’s 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, SOP’s, HPLC-UV, GC, IQ/OQ/PQ.

Job location: Chantilly, VA. Submit résumé referencing job code SEE001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.