Quality Control Analyst

About the role

The Quality Control Analyst will perform analytical testing on raw materials, in‑process samples and finished pharmaceutical or biopharmaceutical products. The role ensures compliance with strict regulatory standards, company specifications and Good Manufacturing Practice (GMP) requirements.

Key responsibilities

• Conduct routine and non‑routine analytical testing using HPLC, GC, UV‑Vis, FTIR, dissolution testing and microbiological assays.
• Record, compile and review analytical data in full compliance with cGMP, data‑integrity principles and SOPs.
• Maintain, calibrate and troubleshoot laboratory instrumentation.
• Assist investigations of Out‑of‑Specification (OOS) or Out‑of‑Trend (OOT) results and support CAPA implementation.
• Participate in SOP authoring, revision and updating.
• Support method verification, validation and transfer activities.

Required profile

• Bachelor’s degree (or higher) in Chemistry, Biochemistry, Microbiology, Pharmacy or a related scientific discipline.
• 0–5 years of experience in a GMP laboratory environment, with exposure to advanced analytical instrumentation.
• Strong knowledge of cGMP guidelines, FDA/EMEA regulatory requirements and data‑integrity principles.
• Proficiency with laboratory software such as Empower and LIMS.
• Excellent written and verbal communication skills for reporting and cross‑functional collaboration.

Required skills

• HPLC
• GC
• UV‑Vis spectroscopy
• FTIR
• Dissolution testing
• Microbiological assays
• cGMP compliance
• FDA/EMEA regulatory knowledge
• Data integrity principles
• Empower software
• LIMS
• Laboratory equipment calibration
• Method verification
• Method validation
• Method transfer
• SOP authoring