Senior QC Analyst - cGMP, FDA-Ready & Trainer

Glenmark Spring; Monroe (NC); Vor Ort; USD 65.000 - 85.000; Vollzeit

Zusammenfassung

Glenmark Monroe QC Lab is seeking a dedicated Analyst to perform analytical testing under cGMP and USFDA guidelines. The role emphasizes data integrity, instrument IOQ/calibration, and support for RM/PM/FP testing under the QC Manager.

The candidate will participate in stability studies and assist in regulatory compliance tasks. The position requires attention to quality systems, CAPA implementation, and potential training duties for QC staff.

Qualifikationen

• Bachelor’s degree in Chemistry or Pharmaceutical Sciences.
• 4+ years in a pharmaceutical manufacturing facility.
• Experience in QC for Stability, Finished Goods, and Raw Materials; some R&D exposure.

Aufgaben

• Be cost effective and vigilant of lab reagents and glassware to stay within budget.
• Maintain quality system controls to prevent market complaints.
• Perform in-process, RM, PM, and finished product testing in QC lab.
• Investigate quality events and perform RCA with SIT involvement.
• Prepare for internal and external audits; ensure readiness of QC Lab.

Kenntnisse

cGMP knowledge

Regulatory guidelines

Six Sigma Green Belt

GMP training

Ausbildung

Bachelor's degree in Chemistry/Pharmaceutical Sciences

Tools

GC

HPLC

Polarography

UV-Vis

FTIR

Jobbeschreibung

Glenmark Monroe QC Lab is seeking a dedicated Analyst to perform analytical testing under cGMP and USFDA guidelines. The role emphasizes data integrity, instrument IOQ/calibration, and support for RM/PM/FP testing under the QC Manager.

The candidate will participate in stability studies and assist in regulatory compliance tasks. The position requires attention to quality systems, CAPA implementation, and potential training duties for QC staff.