QC Auditor I

Company: System One
Location: Iron Station
Posted on: September 24, 2022

Job Description:

Title: QC Auditor I Location: Iron Station, NC area Duration: Contract to hire Schedule: M-F Full Time Start Date: ASAP Responsibilities: The purpose of this position is to review QA/QC documentation, to assess data compliance/validity with regulatory guidelines in the Quality Control Department and ensure that all the work is performed and documented accurately, timely and in compliance with internal procedures and regulatory agencies.

• Provide technical support for the release of raw materials, finished products, and stability data.
• Ensure all recorded data is accurate, legible, complete, and documented in such a manner as to be understood by a 3rd party.
• Review all recorded QC data and assess it for compliance to applicable test methods, GDPs, and adherence to internal SOPs.
• Track and assist in resolution and close out of open and outstanding deviations, invalidations, out of trend reports, and out of specification investigations.
• Track and complete Training Guidelines & Training Effectiveness Tools for Auditor I.
• Ability to occasionally lift 50 pounds Requirements:
  • BS or BA in Chemistry or related science
  • One year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc.).
  • 1 year of experience with FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.) as pertains to a QC Laboratory.
  • Basic understanding of general chemistry principles.
  • Ability to read and interpret technical documentation, such as Monographs, GTMs, and USP/BP Test Methods, Protocols, and FDA Guidance.
  • Consistently audits basic electronic chromatography results analyses (i.e. active assays, IDs, isocratic analyses, etc.) for accuracy, completeness, compliance to GDPs and cGMPs and with no omissions or errors.
  • Equipment and Applications: USP and Empower

Keywords: System One, Gastonia , QC Auditor I, Accounting, Auditing , Iron Station, North Carolina