Description

You will manage day-to-day laboratory operations to ensure product analysis meets required timelines and regulatory standards.

Responsibilities

• Coordinate laboratory operations to ensure HPLC and client testing comply with company policies and safety regulations.
• Manage lot release and stability timelines to prevent delays in product availability.
• Interpret analytical data, resolve technical issues, and assist in troubleshooting quality investigations.
• Create and revise SOPs, testing methods, and test records while providing data for regulatory filings.

Required Skills

• 2+ years of experience in a regulated laboratory environment.
• Hands-on experience working within GMP frameworks.
• Knowledge of GLP standards.
• Experience with Quality Investigations and CAPA processes.
• Proficiency using LIMS for data management.
• Ability to perform HPLC testing and data interpretation.
• Flexibility to work all shifts, including weekend support, though primary hours are during the day.

Preferred Skills

• Experience contributing to continuous improvement projects.

Key Skills

Education

Any Graduate