Senior QC Analyst - cGMP & FDA Readiness Lead

Global Blockchain Talent; Monroe (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Glenmark Pharmaceuticals Inc. in Monroe, USA, is seeking a QC Lab professional to join the analytical team. The role focuses on cGMP-compliant QC testing, data integrity, and instrument calibration in a fast-paced manufacturing environment.

You will contribute to stability studies, method transfer, and regulatory audits, while ensuring timely testing and readiness for internal and external inspections. A Bachelor's degree in Chemistry or Pharmaceutical Sciences is required, with 4+ years in

Qualifications

• Bachelor-level degree in Chemistry or Pharmaceutical Sciences is required.
• 4+ years in pharmaceutical manufacturing with QC experience.
• Knowledge of cGMP, regulatory guidelines, and QA systems.

Responsibilities

• Perform QC analysis in compliance with cGMP and USFDA standards.
• Maintain data integrity and quality systems across QC lab activities.
• Execute IOQ/Calibration for QC instruments with guidance from CQA.
• Support stability studies and documentation for audits.
• Investigate quality events and participate in CAPA and SIT activities.

Skills

cGMP knowledge

Quality control

Documentation

Calibration & maintenance

Education

Bachelor's degree in Chemistry / Pharmaceutical Sciences

Tools

GC

HPLC

Polarography

UV-Vis

FTIR

Job description

Glenmark Pharmaceuticals Inc. in Monroe, USA, is seeking a QC Lab professional to join the analytical team. The role focuses on cGMP-compliant QC testing, data integrity, and instrument calibration in a fast-paced manufacturing environment.

You will contribute to stability studies, method transfer, and regulatory audits, while ensuring timely testing and readiness for internal and external inspections. A Bachelor's degree in Chemistry or Pharmaceutical Sciences is required, with 4+ years in