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.
