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Harba Solutions Inc.

Quality Control Chemist

Harba Solutions Inc., Indianapolis, Indiana, us, 46262

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The Quality Control Chemist is responsible for performing analytical testing of raw materials, in-process samples, and finished products to ensure compliance with GMP, regulatory requirements, and internal quality standards.

Key Responsibilities

Perform routine and non-routine chemical analyses using validated analytical methods

Execute testing using techniques such as

HPLC, LC-MS, GC, UV-Vis, FTIR, pH, conductivity, and titration

Prepare standards, reagents, and mobile phases

Review, analyze, and document test results in compliance with

GMP and Good Documentation Practices (GDP)

Support batch release testing and stability studies

Investigate

out-of-specification (OOS)

and

out-of-trend (OOT)

results

Assist with deviations, CAPAs, method transfers, and validations

Maintain laboratory equipment, calibration, and logbooks

Support internal and external audits (FDA, ISO)

Required Skills & Qualifications

Bachelor’s degree in

Chemistry, Biochemistry, or related field

Hands‑on experience with

LC‑MS and HPLC

preferred

Strong knowledge of

GMP/cGMP

and regulatory requirements

Attention to detail and strong data integrity practices

Ability to work independently in a regulated lab environment

Seniority level

Associate

Employment type

Full‑time

Job function

Research, Quality Assurance, and Manufacturing

Industries

Biotechnology Research

Pharmaceutical Manufacturing

Medical Equipment Manufacturing

Benefits

Medical insurance

Vision insurance

401(k)

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