Quality Control Analytical Chemist II - Malvern, PA
Responsibilities:
- Calibrate, maintain and operator laboratory equipment such as HPLC, GC, GC-HS, FTIR, pH meter, balances, KF, titrators and LCMS
- Conduct GMP analyses of raw materials, in-process materials, final product, and stability samples
- Complete GMP documentation needed to support release of raw materials, intermediates, and final products
- Validate methods for use in GMP environment
- Prepare documents such as methods of analysis, specifications, analytical reports etc.
- Provide analytical support to Process R&D (synthetic R&D) group and collaborate to advance the project
- Participate in method development and optimization as necessary
Qualifications:
- Typically, BS w/ 3-5 years relevant experience or MS w/+2-year relevant experience in pharmaceutical industry. (or relevant fields)
- Previous QC/method development experience well considered
- Knowledge of cGMP regulations, USP, and chromatographic software is required.
- Excellent organizational, communication and documentation skills required.
- Prepositive approach and interest in analytical development, well considered.
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