Quality Control Chemist (Indianapolis)Harba Solutions Inc. • Indianapolis, IN, United States
Quality Control Chemist (Indianapolis)
Harba Solutions Inc. • Indianapolis, IN, United States
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job_description.job_card.job_descriptionBachelors 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.
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 :
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Quality Control Chemist • Indianapolis, IN, United States