Senior Pharmaceutical Quality Control Chemist
Placements24Job Description
Our client, a leading pharmaceutical company renowned for its commitment to innovation and patient well-being, is seeking an experienced Senior Pharmaceutical Quality Control Chemist for their facility in Baltimore, Maryland, US . This role is integral to ensuring the quality, safety, and efficacy of our pharmaceutical products through rigorous analytical testing and process monitoring. You will be responsible for performing a wide range of chemical analyses on raw materials, in-process samples, and finished products using advanced analytical techniques. The ideal candidate will possess a strong background in analytical chemistry, particularly within the pharmaceutical industry, and extensive experience with methods such as HPLC, GC, spectroscopy (UV-Vis, IR, AA), and titration. Your duties will include method development and validation, troubleshooting analytical instrumentation, and maintaining comprehensive laboratory records in compliance with Good Laboratory Practices (GLP) and Good Manufacturing Practices (GMP). You will also play a key role in investigating out-of-specification (OOS) results and implementing corrective and preventive actions (CAPAs). Collaboration with R&D, production, and regulatory affairs teams will be essential to address quality-related issues and support product lifecycle management. We are looking for a meticulous individual with excellent scientific judgment, strong problem-solving skills, and a commitment to maintaining the highest standards of quality and compliance. This is a rewarding opportunity to contribute to the development and manufacturing of life-changing medications.
Key Responsibilities: Perform analytical testing of raw materials, intermediates, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, IR). Develop, validate, and transfer analytical methods according to regulatory guidelines. Troubleshoot and maintain laboratory instrumentation to ensure optimal performance. Investigate out-of-specification (OOS) results and identify root causes. Implement corrective and preventive actions (CAPAs) to address quality deviations. Ensure all laboratory activities comply with GLP, GMP, and other relevant regulatory requirements. Maintain accurate and detailed laboratory notebooks and records. Collaborate with R&D, manufacturing, and regulatory teams on quality-related projects. Contribute to the continuous improvement of quality control processes and procedures. Qualifications: Bachelor's or Master's degree in Chemistry, Pharmaceutical Sciences, or a related field. Minimum of 5 years of experience in pharmaceutical quality control or analytical development. Extensive hands-on experience with analytical instrumentation (HPLC, GC, MS, Spectroscopy). Thorough understanding of GLP and GMP regulations. Proficiency in method development, validation, and transfer. Strong analytical, problem-solving, and critical thinking skills. Excellent attention to detail and accuracy. Effective written and verbal communication skills. Experience with statistical analysis software is a plus.
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