QA Data Reviewer
3 weeks ago
QA DATA REVIEWER
New Brunswick, NJ (ONSITE)
23295
Our client is looking for an QA Data Reviewer who will perform critical in-depth review of all scientific data for Quality Control laboratory documents under general supervision.
WHAT YOU GET TO DO
- 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 guidance.
- 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.
WHAT YOU BRING
- Minimum of three (3) years of experience in a pharmaceutical environment with a minimum two (2) years of experience in chromatography (e.g. HPLC with empower data acquisition software, GC, FTIR, UV and wet chemistry).
- Bachelor’s degree is required.
- 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.
- Knowledge of USP, ICH, FDA, and DEA regulations.
- Knowledge of the operating principles of HPLC, UV, FTIR, GLC, and Malvern particle size analyzers.
Must be able to work for a US based company without requiring visa sponsorship.
COMPENSATION AND BENEFITS
- Salary range is between $70,000 to $80,000 based on experience and qualifications, as well as geographical market and business considerations.
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