Night QC Chemist: Precision Testing & GMP Analysis

Adare Pharmaceuticals; Vandalia (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

Adare Pharma Solutions in Vandalia, Ohio is seeking a Quality Control Chemist to perform moderately complex physical and chemical testing of intermediate and finished products according to written procedures. You will support product release and process validation through timely data reporting.

You will operate instrument software, troubleshoot methods, and maintain calibration records for systems like UV, FTIR, GC, HPLC and IC, while ensuring compliance with cGMP and Data Integrity requirements.

Qualifications

• Some working knowledge of laboratory procedures, equipment, instrumentation, safety procedures and laboratory practices.
• Good understanding of chromatography methods and problem solving.
• Has a thorough understanding of cGMP and Data Integrity documentation requirements.

Responsibilities

• Demonstrate knowledge of various test methods and instrument analysis techniques and be proficient with all sample types and test methods.
• Perform more advanced troubleshooting/maintenance of the instrumentation.
• Conduct complex physical and chemical testing of raw material, intermediate, and finished products to support product release and process validation protocols.
• Operate instrument software applications, set up advanced sequences, troubleshoot software and report data while executing higher complexity methods that utilize UV, FTIR, GC, HPLC, and IC.
• Perform swabbing and analysis of complex manufacturing equipment as required, adhering to cGMP guidelines.
• Maintain and calibrate equipment, review documentation for compliance, and support system change control actions.
• Investigate Out of Specification results, Out of Trend results, and deviations.

Education

Bachelor’s degree in Chemistry or closely related field

Job description

Adare Pharma Solutions in Vandalia, Ohio is seeking a Quality Control Chemist to perform moderately complex physical and chemical testing of intermediate and finished products according to written procedures. You will support product release and process validation through timely data reporting.

You will operate instrument software, troubleshoot methods, and maintain calibration records for systems like UV, FTIR, GC, HPLC and IC, while ensuring compliance with cGMP and Data Integrity requirements.