2923-1

Responsibilities

• Perform routine and non-routine analytical testing using HPLC, UPLC, and other chromatographic techniques.
• Prepare samples, standards, reagents, and mobile phases according to approved procedures.
• Conduct testing of raw materials, intermediates, finished products, stability samples, and cleaning validation samples.
• Analyze and interpret chromatographic data to ensure product quality and regulatory compliance.
• Troubleshoot analytical issues and investigate atypical or out-of-specification (OOS) results.
• Utilize Empower software for instrument control, data acquisition, data processing, and reporting.
• Review chromatographic data for accuracy, completeness, and compliance with data integrity requirements.
• Create, modify, and maintain Empower methods, processing methods, and report templates as required.
• Ensure electronic records comply with 21 CFR Part 11 requirements and company data integrity policies.
• Maintain accurate laboratory notebooks, worksheets, logbooks, and electronic records.
• Follow cGMP, GDP, and laboratory safety procedures.

Requirements

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, Biology, or related discipline.
• 2-5 years of QC laboratory experience in a regulated industry.
• Hands-on experience performing HPLC analysis.
• Strong understanding of data integrity and 21 CFR Part 11 requirements.

Benefits

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law.