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QC Chemist

Harba Solutions Inc.
Indianapolis, IN Full Time
POSTED ON 4/26/2025
AVAILABLE BEFORE 5/25/2025

Job Responsibilities:

  • Perform routine chemical analyses using HPLC, GC, UV-Vis, FTIR, titration, and other analytical techniques.
  • Conduct stability testing and method validations according to ICH guidelines.
  • Prepare and standardize laboratory reagents and solutions.
  • Accurately document test results in accordance with cGMP requirements and Good Documentation Practices (GDP).
  • Review and interpret analytical data, identifying trends or deviations.
  • Maintain, calibrate, and troubleshoot laboratory equipment as needed.
  • Participate in investigations related to out-of-specification (OOS) or out-of-trend (OOT) results.
  • Assist in the development and revision of SOPs, test methods, and validation protocols.
  • Ensure compliance with all applicable regulatory and safety standards (FDA, USP, ICH, etc.).
  • Collaborate with other departments such as R&D, Manufacturing, and Quality Assurance to support product release and continuous improvement initiatives.

Qualifications:

  • Bachelor’s or Master’s degree in Chemistry, Biochemistry, or a related field.
  • 2–3 years of relevant experience in a QC laboratory within the pharmaceutical industry.
  • Hands-on experience with analytical instruments (e.g., HPLC, GC, UV-Vis, FTIR).
  • Knowledge of USP/NF monographs and pharmaceutical regulatory guidelines (FDA, cGMP, ICH).
  • Strong analytical thinking, problem-solving skills, and attention to detail.
  • Excellent organizational and time-management abilities.
  • Proficient in Microsoft Office and Laboratory Information Management Systems (LIMS) is a plus.

Salary : $60,000 - $80,000

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