Senior Quality Control Laboratory Manager

4 weeks ago


Chantilly, Virginia, United States Granules Pharmaceuticals Full time

Job Summary:

As a Director of Quality Control and Compliance at Granules Pharmaceuticals, you will oversee the Quality Control Laboratory, ensuring accurate analytical chemical testing results and adherence to company protocols. You will represent the QC department in scientific and technical discussions with clients, vendors, and FDA representatives. Additionally, you will build and implement effective laboratory systems, processes, and teams for smooth lab operation.

Responsibilities:

  • Represent QC department in scientific and technical discussions with clients, vendors, and FDA representatives
  • Build and implement effective laboratory systems, processes, and teams for smooth lab operation
  • Oversee Quality Control Laboratory to ensure accurate analytical chemical testing results and adherence to company protocols
  • 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

Requirements:

  • Bachelor's Degree in Chemistry, Biochemistry, Pharmaceutical Science, or Physical Chemistry
  • 5 years of experience in the offered job
  • Skills and knowledge in QC Validations, OOT, cGMP/ICH, STPs, SOP's, HPLC-UV, GC, IQ/OQ/PQ

Location: Chantilly, VA. Please submit your résumé referencing job code SEE001 to HR, Granules Pharmaceuticals, Inc., 3701 Concorde Parkway, Chantilly, VA 20151.


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