Quality Control Analyst: GMP Lab Specialist & Trainer

Glenmark Pharmaceuticals; Monroe (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

Glenmark Pharmaceuticals, Inc., USA in Monroe is seeking a QC Lab professional to perform analytical testing in a cGMP environment, reporting to the QC Manager. The role focuses on timely analytical testing and data integrity to support regulatory compliance.

The candidate will work with HPLC, UV-Vis and FTIR instruments, participate in tech transfer, and ensure readiness for audits. BSc in Chemistry with Biochem concentration and 1–3 years of pharma QC experience are required; training and GMP

Qualifications

• Bachelor’s degree in chemistry with biochemistry focus.
• 1–3 years of experience in pharmaceutical QC manufacturing.
• Experience with Stability testing, Finished Goods, and some R&D.
• Strong knowledge of GMP, validations, and regulatory guidelines.

Responsibilities

• Perform QC analyses in compliance with cGMP and USFDA standards.
• Maintain data integrity and quality systems in QC lab.
• Calibrate and IOQ/Calibration for instruments with guidance.
• Execute RM/PM/FD testing and in-process sampling.
• Assist in tech transfer and cleaning validation.
• Ensure readiness for internal and external audits.
• Train QC staff on systems and SOPs.
• Track stability samples and process validation samples.
• Support documentation updates and CAPA implementation.

Skills

cGMP Knowledge

Regulatory Guidelines

Quality Assurance

Six Sigma Basics

Education

B.Sc. in Chemistry with Biochemistry concentration

Tools

HPLC

UV-Vis

FTIR

Job description

Glenmark Pharmaceuticals, Inc., USA in Monroe is seeking a QC Lab professional to perform analytical testing in a cGMP environment, reporting to the QC Manager. The role focuses on timely analytical testing and data integrity to support regulatory compliance.

The candidate will work with HPLC, UV-Vis and FTIR instruments, participate in tech transfer, and ensure readiness for audits. BSc in Chemistry with Biochem concentration and 1–3 years of pharma QC experience are required; training and GMP