PTS Advance is actively recruiting an Analytical R&D Data Reviewer for our pharmaceutical client, located near Easton, PA. This Data reviewer will be responsible for ensuring data and documentation developed in the Analytical R&D lab is reviewed for accuracy, completeness, and cGMP compliant. 

This your opportunity to join an established and rapidly growing company on a full time basis, with the encouragement and provided training for internal growth.

Requirements

• Bachelor's degree in Chemistry or a related study.
• Minimum of 3 years hands-on in cGMP analytical data review and pharmaceutical review/analysis. 
• Demonstrated work knowledge of equipment/analytical techniques related to laboratory instruments (HPLC, UV/Vis/ pH analyzer, UPLC, etc). 
• Demonstrated understanding of GMP, FDA, and ICH guidelines. 
• Ability to utilize lab instrument data software. Lab Management System proficiency.
• Excellent written and oral skills.
• Ability to work independently and collaboratively.
• Proficient in microsoft suite.

Abbreviated Duties

• Verify completeness of documentation. Ensures compliance to GMP requirements.
• Review/approve test results (raw data, raw materials electronic data, finished products, samples)
• Review audit trails and equipment calibration status. Understanding of experiments and Analyses. 
• Responsible for ensuring notebooks and logbooks are reviewed and completed in compliance. 
• Complies to SOPs. Provide training of new hires. Create and maintain training forms. 
• Additional duties. 

To schedule a confidential call, please apply here or email brittany.antonelis@ptsadvance.com.