Category: Scientific & Clinical
Title: QC Auditor I
Location: Iron Station, NC area
Duration: Contract to hire
Schedule: M-F Full Time
Target Start Date: ASAP
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
Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.
- 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