QC Auditor: Compliance & Documentation Specialist

Cosette Pharmaceuticals, Inc.; Lincolnton (NC); On-site; USD 52,000 - 76,000; Full time

Job summary

Cosette Pharmaceuticals, Inc. in Lincolnton, NC seeks a QA/QC Auditor I to review QA/QC documentation and ensure data compliance with regulatory guidelines. You will support release of materials, review QC data, and help close deviations in a fast-paced manufacturing setting.

The role requires a BS in Chemistry or related science with experience in regulated environments and familiarity with FDA regulations (cGMP, GDPs, USP/BP). Safety and procedural compliance are essential.

Qualifications

• BS or BA in Chemistry or related science with 1 year of auditing experience in a regulated environment (FDA, GLP).
• Familiarity with FDA regulations (cGMP, GDPs, USP/BP) for QC laboratory.
• Ability to read and interpret technical docs such as Monographs, GTMs, and USP/BP methods.

Responsibilities

• Provide technical support for release of raw materials, finished products, and stability data.
• Ensure all recorded data is accurate, legible, complete, and understandable by a 3rd party.
• Review recorded QC data for compliance to test methods, GDPs, and internal SOPs.
• Track and assist in resolution of deviations, invalidations, out of trend, and out of specification investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.
• Other duties as assigned by management

Skills

Attention to detail

Math proficiency

Documentation literacy

cGMP knowledge

Education

BS in Chemistry

Tools

USP

Empower

Job description

Cosette Pharmaceuticals, Inc. in Lincolnton, NC seeks a QA/QC Auditor I to review QA/QC documentation and ensure data compliance with regulatory guidelines. You will support release of materials, review QC data, and help close deviations in a fast-paced manufacturing setting.

The role requires a BS in Chemistry or related science with experience in regulated environments and familiarity with FDA regulations (cGMP, GDPs, USP/BP). Safety and procedural compliance are essential.