QC Chemist — Pharma Analytics & Method Validation

Harba; Indianapolis (IN); On-site; Full time

Job description

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.