ClinLab Staffing
Data Reviewer IIINew 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 SOPs, 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).