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).