QC Analyst

Purpose

Provide analytical chemistry testing and support to site operations, ensuring compliance with cGMP/cGLP requirements and supporting the release of raw materials, intermediates, and finished products.

Key Responsibilities

• Perform and review analytical testing and laboratory data.
• Investigate and document OOS results and support data trending and CoA generation.
• Maintain analytical methods, specifications, and SOPs in line with regulatory requirements.
• Review laboratory notebooks, analytical reports, and quality documentation.
• Support equipment qualification and validation activities (IQ/OQ/PQ).
• Train analysts on methods, procedures, and updates as required.
• Collaborate with QA, Production, Engineering, Planning, and QC teams.
• Ensure compliance with cGMP, cGLP, data integrity, and laboratory quality standards at all times.

Required Skills & Experience

• Analytical chemistry experience in a GMP-regulated environment.
• Strong understanding of cGMP/cGLP requirements.
• Excellent attention to detail and documentation skills.
• Experience reviewing analytical data and laboratory records.
• Strong communication and cross-functional collaboration skills.
• Preferred Experience
• SoftMax® software
• ELISA
• UV analysis
• Osmolality testing
• Oxygen headspace analysis
• SDS-PAGE
• Biacore receptor-binding assays
• Karl Fischer moisture testing
• HIAC particulate testing
• Strong micropipetting technique and time management skills.