Position Summary
The Analytical Chemist II performs advanced chemical analyses in a high-volume laboratory environment, with primary focus on HPLC, assay, potency, and impurity testing. This role leads the execution of complex testing, provides technical guidance to junior staff, and ensures regulatory compliance and data integrity. The position supports process improvements, method validation, and training initiatives.
What You Will Do
- Perform routine and moderately complex chemical analyses, including HPLC, assay, potency, and impurity testing.
- Lead sample tracking, test execution, and result reporting, ensuring accuracy, completeness, and compliance.
- Independently identify, troubleshoot, and resolve unexpected test results or equipment issues.
- Conduct instrument maintenance, calibration, and advanced troubleshooting with minimal supervision.
- Review laboratory SOPs and contribute to their revision or creation; provide guidance to junior staff on SOP compliance.
- Ensure compliance with cGMP, cGLP, ISO 17025, USP, A2LA, and company SOPs.
- Participate in continuous improvement initiatives, method optimization, and high-volume workflow management.
- Train and mentor Analytical Chemist I and entry-level staff.
- Support internal audits, safety inspections, and client audits as needed.
- Assist with special projects, technical evaluations, and cross-functional laboratory initiatives.
- Communicate findings, trends, and recommendations effectively to laboratory and quality leadership.
Who You Are
- Bachelor’s degree in Chemistry, Biochemistry, or a related field; Master’s degree preferred.
- 3–5 years of experience in a regulated analytical laboratory (cGMP, cGLP, ISO 17025, USP, A2LA).
- Experience with sample preparative chemistry and wet chemistry analysis.
- Certified Pharmacy Technician (CPhT) a plus.
- Advanced proficiency with HPLC, UV-Vis, and other analytical instrumentation.
- Strong understanding of instrumental analysis procedures used in modern chemistry laboratories.
- Knowledge of sampling methods and quality control systems.
- Proven ability to troubleshoot analytical methods and instrumentation independently.
- Experience reviewing laboratory data, quality documentation, and regulatory compliance records.
- Ability to lead, mentor, and train junior staff while supporting workflow optimization.
- Excellent attention to detail and organizational skills, with a strong focus on data integrity.
- Proficient in Microsoft Office and laboratory data management systems.
- Strong verbal and written communication skills, with the ability to collaborate effectively across teams.
Who We Are
Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results. Learn more at www.eagleanalytical.com.
