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Quality Control Chemist

Quality Control Chemist

Harba Solutions Inc.Indianapolis, IN, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

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 :

  • Bachelor’s 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.
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