QA Data Reviewer

3 weeks ago


New Brunswick NJ United States Wimmer Solutions Full time

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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