Quality Control Analytical Chemist II. - Flamma spa
Malvern, PA
About the Job
Responsibilities:
• Calibrate, maintain and operate 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, specification, 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.