Indianapolis 70K - 100K Permanent
Job Responsibilities:
Conduct analytical testing of raw materials, in-process samples, and finished pharmaceutical products using techniques such as HPLC, GC, UV-Vis, FTIR, dissolution, and titration.
Document and review laboratory results, maintaining accurate and complete records in compliance with cGMP and company SOPs.
Troubleshoot analytical methods and equipment as needed to ensure reliable results.
Participate in method development, validation, and transfer projects.
Perform stability testing and support stability program initiatives.
Investigate out-of-specification (OOS) results and participate in root cause analysis and corrective actions.
Ensure laboratory compliance with safety protocols, quality standards, and regulatory requirements (FDA, EMA, ICH).
Collaborate with Quality Assurance, Manufacturing, and R&D teams to support product release and quality improvement initiatives.
Maintain and calibrate laboratory equipment according to SOPs and regulatory guidelines.
Qualifications:
Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field; Master’s preferred.
1–5 years of experience in pharmaceutical quality control or analytical laboratory environment.
Strong knowledge of cGMP, SOPs, and regulatory requirements in the pharmaceutical industry.
Hands-on experience with HPLC, GC, UV-Vis, FTIR, and other analytical instrumentation.
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