Senior Pharmaceutical Quality Control Chemist

Our client, a prominent pharmaceutical company, is seeking a highly skilled Senior Pharmaceutical Quality Control Chemist to join their remote-first team. This position is crucial for ensuring the quality, safety, and efficacy of our pharmaceutical products through rigorous analytical testing and compliance with regulatory standards. The ideal candidate will possess extensive experience in analytical chemistry techniques relevant to drug development and manufacturing. You will be responsible for developing, validating, and executing test methods for raw materials, in-process samples, and finished products. Key responsibilities include operating and maintaining advanced analytical instrumentation (e.g., HPLC, GC, MS, FTIR), troubleshooting analytical issues, and documenting all laboratory activities according to GMP guidelines. You will also play a key role in stability studies, investigating out-of-specification (OOS) results, and contributing to continuous process improvement initiatives. This role demands meticulous attention to detail, a strong understanding of pharmaceutical regulations (FDA, ICH), and the ability to work independently in a remote setting. Proactive problem-solving and a commitment to upholding the highest quality standards are essential.

Responsibilities: Perform analytical testing on raw materials, intermediates, and finished pharmaceutical products using various techniques (e.g., HPLC, GC, UV-Vis, FTIR, KF Titration). Develop, validate, and transfer analytical methods in accordance with regulatory guidelines (e.g., ICH, USP, FDA). Operate, calibrate, and maintain laboratory instruments and equipment. Troubleshoot analytical methods and instrumentation issues, providing timely resolutions. Investigate and document Out-of-Specification (OOS) results and deviations, implementing corrective and preventive actions (CAPAs). Participate in stability studies, analyzing samples and reporting data. Review and approve analytical data and reports generated by QC analysts. Ensure all laboratory activities are conducted in compliance with current Good Manufacturing Practices (cGMP) and relevant regulatory requirements. Collaborate with R&D, Manufacturing, and Regulatory Affairs departments on product development and lifecycle management. Contribute to the continuous improvement of QC processes and methodologies. Mentor and provide technical guidance to junior QC chemists. Qualifications: Master's or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related field. Bachelor's degree with significant relevant experience will also be considered. Minimum of 5-7 years of experience in pharmaceutical quality control, with a strong focus on analytical chemistry. Extensive hands-on experience with analytical instrumentation such as HPLC, GC, Mass Spectrometry (MS), and spectroscopy. Thorough understanding of GMP, ICH, USP, and FDA guidelines. Proficiency in method development and validation. Excellent problem-solving, analytical, and critical-thinking skills. Strong documentation and technical writing skills. Ability to work independently, manage multiple projects, and meet deadlines in a remote environment. Experience with LIMS (Laboratory Information Management System) is a plus. This is a fully remote position, requiring a dedicated home office setup and reliable internet connection.

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