Job Description: Analytical Chemist – Method Validation- Gurnee, Illinois
Full benefits- Paid time off, Paid holidays, Paid vacation days, Paid Sick days
Key Responsibilities

1. Test Method Validation:
   
2. Develop and validate test methods, including documentation such as Method Validation Protocols, Validation Reports, and Standard Operating Procedures (SOPs).
   

3. Maintain training records concerning the validated methods.
   
   
   

4. Test Method Verification:
   
5. Ensure SOPs are adhered to for method verification.
   
   
   

6. Test Method Validation for Specific Analyses:
   
7. Validate methods for FTIR, GC-FID for EG/DEG concentration, titration assays, residue on ignition, and GC-FID for ethylene oxide and 1,4-dioxane.
   

8. Document method development reports and SOPs for analysis procedures
   
   
   

9. Analytical Instrumentation:
   
10. Perform installation qualification, operational qualification, and performance qualification (IQ/OQ/PQ).
    

11. Maintain calibration records, preventative maintenance records, and SOPs for equipment operation.
    

12. Manage change control records, incident or deviation reports, and audit trails.
    

13. Ensure equipment is cleaned and troubleshooted regularly.
    
    
    

14. Equipment Validation:
    
15. Validate FTIR, GC-FID equipment through IQ/OQ/PQ protocols.
    
    
    

16. Data Collection and Reporting (DCR):
    
17. Follow DCR guidelines to maintain accuracy, consistency, and reliability in data.
    

18. Ensure data collection uses approved and calibrated instruments and standardized sampling methods.
    

19. Maintain accurate documentation and ensure data reporting is accurate, timely, and confidential.
    

20. Implement quality control through regular audits, continuous staff training, and corrective measures for data anomalies.
    
    
    

21. Training:
    
22. Organize SOPs and policies into curricula.
    

23. Document and ensure all training records are uploaded into the management system.
    

24. Identify and document Subject Matter Experts (SMEs) and trainers.
    
    
    

25. Additional Policies and Procedures:
    
26. Develop SOPs for Out-Of-Specification (OOS) and Out-Of-Trend (OOT) results, deviation handling, and 21 CFR 11 compliance.
    

27. Maintain product stability and sample retention records.
    
    

Qualifications

• Bachelor’s or master’s degree in chemistry or a related field.
  

• Extensive experience in method validation and instrumentation.
  

• Strong documentation skills.
  

• Commitment to maintaining data integrity and following industry guidelines.

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