Data Reviewer III Job at ClinLab Staffing, New Brunswick, NJ

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  • ClinLab Staffing
  • New Brunswick, NJ

Job Description

Job Description

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).

Job Tags

Contract work,

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