Senior QC Chemist - Pharma Quality & Compliance

MSN Pharmaceuticals Inc.

New Jersey

Presencial

USD 90.000 - 120.000

Jornada completa

Hace 2 días
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Descripción de la vacante

MSN Pharmaceuticals Inc. in New Jersey is seeking a QC Senior Chemist to oversee quality control operations in an FDA-regulated cGMP environment, testing raw materials, in-process blends, and finished drug products.

You will perform analytical testing using HPLC, GC, UV-Vis, Karl Fischer, IR, and dissolution instruments; ensure data integrity and support method validation, transfer, and audits. 5–10 years of experience required.

Formación

  • 5–10 years pharmaceutical QC experience.
  • Experience with HPLC/GC/UV-Vis and dissolution techniques.
  • Familiarity with FDA, cGMP, GLP, GDP, USP/NF and data integrity.

Responsabilidades

  • Oversee QC operations and test raw materials, in-process blends, and finished products.
  • Perform and review analytical testing using listed instruments.
  • Calibrate instruments, perform system suitability checks, troubleshoot, and maintain equipment.
  • Review CoAs and laboratory records for accuracy and compliance.
  • Investigate OOS/OOT results, deviations, and CAPA delivery.
  • Ensure compliance with FDA, cGMP, GLP, GDP, USP/NF, and data integrity standards.
  • Support method validation, verification, transfer, and stability studies.
  • Provide guidance and training to QC staff and junior personnel.
  • Coordinate with QA and Production to resolve quality issues; support audits and inspections.

Conocimientos

Analytical testing
Quality control
Regulatory compliance

Herramientas

HPLC
GC
UV-Vis
Karl Fischer
IR
Dissolution testing

Descripción del empleo

MSN Pharmaceuticals Inc. in New Jersey is seeking a QC Senior Chemist to oversee quality control operations in an FDA-regulated cGMP environment, testing raw materials, in-process blends, and finished drug products.

You will perform analytical testing using HPLC, GC, UV-Vis, Karl Fischer, IR, and dissolution instruments; ensure data integrity and support method validation, transfer, and audits. 5–10 years of experience required.

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