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Basic Purpose:

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.

Essential Functions and Responsibilities:

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 and Training Effectiveness Tools for Auditor I. Other duties as assigned by management

Knowledge, Skills, Qualifications and Physical Requirements:

Education/Training/Work Experience:

BS or BA in Chemistry or related science with one year of experience auditing laboratory documentation in a regulated environment (i.e. FDA, GLP, etc.). Prior experience (one year preferred) or ability to learn, FDA regulations (cGMP, GDPs, adherence to USP, BP, etc.) as pertains to a QC Laboratory.

Specialized Knowledge and Skills:

Basic understanding of general chemistry principles. Proficient in mathematics. 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 Empower Work Environment and Physical Demands:

Safety Glasses Laboratory Coat Appropriate shoes and clothing This position requires minimal physical requirements. The incumbent is however, required to have manual dexterity and will be required to sit for hours using a computer. 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