QC Chemist III

The Impact You Will Make

Transform Lives Through Innovation
Join a rapidly expanding pharmaceutical CDMO where your work directly impacts patient health outcomes worldwide.

Responsibilities

• Perform and coordinate routine setup, calibration, operation, and maintenance of laboratory instruments and equipment.
• Analyze samples using a variety of analytical techniques and instrumentation in accordance with established procedures and specifications.
• Lead or coordinate testing schedules to support business priorities and timely completion of laboratory activities.
• Prepare and standardize solutions as defined by analytical methods and applicable compendia.
• Assist with or coordinate routine verification of laboratory standards, solutions, and documentation.
• Practice cGMP principles, including proper documentation, data archival, peer review, and immediate notification of out-of-specification (OOS) results.
• Compile analytical reports and ensure documentation is accurate, complete, and compliant.
• Demonstrate advanced knowledge of chemistry theories, analytical techniques, compendia requirements, and laboratory quality systems.
• Review and revise SOPs, analytical methods, and related documentation while recommending improvements to testing procedures.
• Perform compendial verifications and support method validations for new product technical transfers, including protocol writing, execution, and reporting.
• Lead and coordinate training activities to qualify colleagues on additional methods, procedures, and compendial testing.

Qualifications

• Knowledge of USP, EP, and other applicable compendia, cGMP guidelines, FDA regulations, laboratory safety procedures, SDS requirements, and laboratory instrumentation.
• Strong understanding of inorganic and organic chemistry principles, including both large and small molecule pharmaceutical products.
• Bachelor's degree in Chemistry, Biochemistry, or a related science field with a minimum of 7 years of experience, or a Master's degree in Biochemistry with 3–5 years of experience, or an equivalent combination of education and experience.
• Laboratory experience in a GMP-regulated environment is highly desirable, particularly with both large and small molecule pharmaceuticals and technical transfer activities.
• Ability to read and interpret compendial methods, SOPs, technical procedures, professional journals, and governmental regulations, and to author scientific and technical documentation.
• Ability to perform basic mathematical and statistical functions and graph data.
• Strong problem-solving skills with the ability to collect data, establish facts, and draw valid conclusions.
• Proficiency with Microsoft Office applications, including Word, Excel, and Outlook.
• Experience with chromatography data systems, particularly Empower, is preferred.
• Experience with biochemistry and analytical techniques including ELISA, SDS-PAGE, Western Blot, Protein Concentration, HPLC, GC, chromatography data software, titrations, pH, Karl Fischer, and general wet chemistry/compendial testing.
• Ability to manage multiple priorities and work effectively under strict production and performance deadlines.
• Willingness to work beyond a typical work schedule, including occasional weekends and holidays as business needs require.