Data Reviewer III

Data Reviewer III—New Brunswick, NJ

With minimal direction from management, this individual :

• Performs critical in-depth review of all scientific data for Quality Control laboratory documents (including, but not limited to review of raw data of in-process, API / Excipients, Finished Products, Stability, Cleaning Verification, Instrument calibration records, Contract laboratory results notebooks, reports, and materials for ANDA submissions) for completeness, integrity and accuracy.
• Demonstrates a thorough knowledge of approved SOP’s, compendia (USP, BP, and EP), ICH, FDA and other regulatory guidances.
• Ensures that all documents are in compliance with cGMPs and the site operating procedures under the direction of QA management.
• Supports systems to ensure the successful completion of Departmental goals and objectives.
• Minimum of a Bachelors.
• Extensive knowledge of pharmaceutical analysis.
• Ability to review laboratory records with minimal supervision within the framework of cGMP / GLP for analytical laboratories.
• Good understanding of EHS and OSHA safety guidelines.
• Extensive knowledge of USP, ICH, FDA, and DEA regulations.
• Extensive knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
• Demonstrated excellent communication : verbal, written and presentation skills.
• A self-starter with a hands-on approach and a can-do attitude.
• Minimum of six (6) years of experience in a pharmaceutical environment with a minimum four (4) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).