Granules Pharmaceuticals, Inc.
Director, Quality Control Lab (Chantilly, VA)
Granules Pharmaceuticals, Inc., Chantilly, Virginia, United States, 22021
Job Description
Join Granules Pharmaceuticals, Inc. as a
Director, Quality Control Lab (Chantilly, VA) . Description : As a
Director, Quality Control (Chantilly, VA)
at Granules Pharmaceuticals Inc, you will be 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 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. Requirements : Must have a Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Science, or Physical Chemistry plus 5 years experience in the job offered. Require skills and knowledge in QC Validations, OOT, cGMP/ICH, STPs, SOP’s, HPLC-UV, GC, IQ/OQ/PQ. Granules Pharmaceuticals, Inc. is an Equal Opportunity Employer.
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Join Granules Pharmaceuticals, Inc. as a
Director, Quality Control Lab (Chantilly, VA) . Description : As a
Director, Quality Control (Chantilly, VA)
at Granules Pharmaceuticals Inc, you will be 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 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. Requirements : Must have a Bachelor’s Degree in Chemistry, Biochemistry, Pharmaceutical Science, or Physical Chemistry plus 5 years experience in the job offered. Require skills and knowledge in QC Validations, OOT, cGMP/ICH, STPs, SOP’s, HPLC-UV, GC, IQ/OQ/PQ. Granules Pharmaceuticals, Inc. is an Equal Opportunity Employer.
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