Position Summary
The Quality Control Chemist is responsible for the review, approval, and maintenance of analytical chemistry documentation and quality records to ensure compliance with regulatory and accreditation requirements. This role supports Eagle Analytical’s Quality Management System by reviewing analytical methods, validation documentation, laboratory data, reports, and quality investigations while ensuring adherence to cGMP, cGLP, ISO 17025, A2LA, and USP standards. The position works closely with laboratory operations to maintain data integrity, regulatory compliance, and continuous improvement across chemistry testing functions.
What You Will Do
- Ensure compliance with Eagle Analytical policies, Standard Operating Procedures (SOPs), and the Quality Management System.
- Interpret and apply regulatory and accreditation standards, including ISO 17025, cGMP, cGLP, USP, and A2LA requirements.
- Support regulatory inspections, client audits, and accreditation assessments as required.
- Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
- Review and approve analytical test methods and related documentation for chemistry testing, including UV-Vis spectrophotometry, HPLC, HPLC-MS/MS, GC-MS, and other analytical instrumentation.
- Review laboratory test reports, chemistry logs, worksheets, validation protocols, and validation reports.
- Ensure analytical data integrity, accuracy, completeness, and traceability.
- Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
- Evaluate root cause analyses and corrective action plans for process and laboratory-related issues.
- Create audit finding reports and determine appropriate corrective and preventive actions.
- Support and conduct internal audits of quality systems and documentation.
- Perform routine walk-through audits to ensure ongoing compliance across laboratory departments.
- Manage auditing, storage, and retention of quality documentation and quarantined materials.
- Prepare and maintain quality-related training materials as assigned.
- Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
- Assist in creating and maintaining quality manuals, procedures, and other controlled quality documents.
- Perform additional duties and special projects as assigned to support quality and regulatory objectives.
Who You Are
- Bachelor’s degree in Chemistry, Analytical Chemistry, or a related scientific discipline required.
- Experience in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
- Experience supporting analytical chemistry testing laboratories is strongly preferred.
- Strong understanding of analytical chemistry techniques and instrumentation, including HPLC, HPLC-MS/MS, GC-MS, and UV-Vis.
- Working knowledge of method validation, data review, and laboratory quality systems.
- Experience reviewing GMP/GLP documentation and quality investigations.
- Strong attention to detail and commitment to data integrity and compliance.
- Excellent written and verbal communication skills.
- Ability to work independently while collaborating effectively with cross-functional teams.
- Proficiency with Microsoft Office applications and electronic document management systems.
- ASQ preferred
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.
