QC Auditor I

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

Benefits

System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.