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August Bioservices - Nashville, TN
posted about 2 months ago
About the position
The Quality Control Lead at August Bioservices is responsible for performing chemical analyses of raw materials and finished products in compliance with cGMP guidelines. This role involves supporting laboratory chemists through training and expertise in USP/EP monograph testing, maintaining knowledge of testing methods, and leading investigations. The Lead will also perform method verifications and transfers, ensuring best practices in chromatography and quantitative analysis are followed.
Responsibilities
- Perform chemical analyses of raw materials and finished products under cGMP guidelines.
- Support laboratory chemists through training and expertise in USP/EP monograph testing.
- Maintain a safe, clean, and organized work area.
- Perform laboratory testing on raw materials and finished products, including in-process and stability samples.
- Prepare test solutions, compounds, or reagents for analysis.
- Accurately perform various wet chemistry techniques and chromatographic analyses.
- Perform major maintenance and troubleshooting on analytical equipment.
- Work in cross-functional teams to complete projects, transfers, and investigations.
- Document all necessary information in compliance with cGMP requirements.
- Create and execute method protocols and reports.
Requirements
- Bachelor's degree in chemistry, biology, or related science and 7+ years of pharmaceutical experience, or a master's degree in chemistry, biology, or related science and 3+ years of pharmaceutical experience.
- Experience in cGMP laboratory environments.
- Proficiency in analytical techniques including HPLC, GC, and Mass Spectroscopy.
- Strong communication skills and ability to train others.
Nice-to-haves
- Experience with root cause analysis and CAPA processes.
- Familiarity with regulatory guidelines and quality management systems.
Benefits
- Competitive salary range of $70.6K - $89.4K per year.
- Opportunities for career growth and development.
- Dynamic work environment in a high-growth company.
