QC Chemist

Harba; Fishers (IN); On-site; USD 40,000 - 65,000; Full time

Job summary

Harba in Indiana is seeking a laboratory professional to perform chemical, physical, and analytical testing on raw materials, in-process samples, and finished goods using established methods.

You will operate and maintain HPLC, GC, FTIR, UV-Vis spectrophotometers and other equipment, document results, and ensure compliance with FDA/USP/ISO standards, GMP/GLP data integrity, and safety protocols.

Responsibilities

• Perform chemical, physical, and analytical testing on materials.
• Operate laboratory instruments like HPLC, GC, FTIR, UV-Vis, titrators.
• Document results in notebooks or LIMS per GMP/GLP data integrity standards.
• Compare results to specifications and report OOS/OOT per procedures.
• Prepare reagents, standards, and solutions needed for testing.
• Calibrate and maintain laboratory instruments; keep calibration logs.
• Assist with investigations into OOS results, deviations, and CAPA documentation.
• Ensure compliance with SOPs, safety protocols, and regulatory requirements (FDA, USP, ISO).
• Participate in method validation, method transfer, and stability testing programs.
• Maintain a clean, organized, and safe laboratory environment.
• Support audits with documentation and test records.
• Collaborate with production, R&D, and regulatory teams to resolve quality issues.

Job description

Job Responsibilities

• Perform chemical, physical, and analytical testing on raw materials, in-process samples, and finished goods using established test methods
• Operate and maintain laboratory instrumentation such as HPLC, GC, FTIR, UV-Vis spectrophotometers, titrators, and other analytical equipment
• Accurately document test results, calculations, and observations in laboratory notebooks and/or LIMS in accordance with GMP/GLP data integrity standards
• Compare test results against approved specifications and report out-of-specification (OOS) or out-of-trend (OOT) results per established procedures
• Prepare reagents, standards, and solutions needed for testing
• Perform calibration, qualification, and routine maintenance of laboratory instruments; maintain calibration logs
• Support investigations into OOS results, deviations, and customer complaints; assist with root cause analysis and CAPA documentation
• Ensure compliance with SOPs, safety protocols, and regulatory requirements (FDA, USP, ISO, etc.)
• Participate in method validation, method transfer, and stability testing programs as needed
• Maintain a clean, organized, and safe laboratory work environment
• Support internal and external audits by providing accurate documentation and test records
• Collaborate with production, R&D, and regulatory teams to resolve quality issues