Quality Control Chemist (Indianapolis)

Job Responsibilities: Perform qualitative and quantitative chemical analyses using techniques such as HPLC, GC, UV-Vis, FTIR, and titrations. Prepare and standardize reagents, solutions, and buffers. Conduct testing on raw materials, intermediates, and finished products according to approved methods and SOPs. Document all testing activities clearly and accurately in compliance with cGMP and ALCOA+ principles. Interpret and evaluate analytical data, ensuring results meet established specifications. Participate in method validation, equipment calibration, and troubleshooting as needed. Maintain laboratory equipment and ensure proper functioning through routine maintenance and calibration. Assist in investigations of OOS (Out of Specification), OOT (Out of Trend), and deviations. Collaborate with QA, production, and R&D departments to support manufacturing and product release. Qualifications: Bachelors degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field. Minimum 2 years of hands-on experience in a QC laboratory within the pharmaceutical or biotech industry. Proficient in analytical techniques (e.g., HPLC, GC) and good laboratory practices. Solid understanding of cGMP, USP/EP, and FDA regulatory requirements.

Created: 2025-09-15