Senior QC Analyst – cGMP & Investigations Lead

Glenmarkpharma; Monroe (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

Glenmark Pharmaceuticals Inc., USA is seeking a QC Lab professional to join the Monroe manufacturing facility. You will perform QC analyses in a cGMP environment, ensure data integrity, and support instrument IOQ/calibration under guidance of the QC Manager.

Responsibilities include testing RM, PM and in-process samples, contributing to investigations, CAPA, and audits, and training QC personnel on systems and SOPs to uphold regulatory compliance with USFDA and global standards.

Qualifications

• Bachelor’s degree in Chemistry or Pharmaceutical Sciences required.
• 4+ years in pharmaceutical manufacturing QC.
• Experience with GC, HPLC, UV-Vis, FTIR and related lab equipment.

Responsibilities

• Perform QC analysis in cGMP-compliant QC lab.
• IOQ/Calibration for instruments in QC lab.
• Investigate quality events and perform RCA as SIT member.
• Maintain readiness for internal/external audits.
• Lead training for QC-related systems and SOPs.
• Support technology transfer and cleaning validation.

Skills

cGMP

Validations

Regulatory guidelines

QMS

Change control

Six Sigma

GMP trainer

Education

Bachelor's degree in Chemistry / Pharmaceutical Sciences

Tools

GC

HPLC

Polarography

Particulate Matter

UV-Vis

FTIR

Job description

Glenmark Pharmaceuticals Inc., USA is seeking a QC Lab professional to join the Monroe manufacturing facility. You will perform QC analyses in a cGMP environment, ensure data integrity, and support instrument IOQ/calibration under guidance of the QC Manager.

Responsibilities include testing RM, PM and in-process samples, contributing to investigations, CAPA, and audits, and training QC personnel on systems and SOPs to uphold regulatory compliance with USFDA and global standards.