QC Auditor: Data Integrity & Regulatory Compliance

Cosette Pharmaceuticals Inc.; Lincolnton (NC); On-site; USD 60,000 - 85,000; Full time

Job summary

Cosette Pharmaceuticals Inc. in Lincolnton, NC, is seeking a QA/QC Documentation Auditor to review laboratory records, ensure data integrity, and support regulatory compliance in the Quality Control Department.

The role involves approving raw materials, finished products, and stability data, tracking deviations, and maintaining documentation according to FDA guidance and GDPs, with emphasis on accuracy and timely reporting.

Qualifications

• BS or BA in Chemistry or related science; one year of experience auditing laboratory documentation in a regulated environment (FDA, GLP).
• Experience or ability to learn FDA regulations (cGMP, GDPs, USP/BP) as pertains to a QC Laboratory.

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 for third-party understanding.
• Review recorded QC data for compliance with test methods, GDPs, and internal SOPs.
• Track and assist in resolution of open deviations, invalidations, OOT, and OOS investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.

Skills

Auditing laboratory documentation

Attention to detail

Mathematics

Reading technical docs

Education

BS or BA in Chemistry or related science

Tools

Empower

Job description

Cosette Pharmaceuticals Inc. in Lincolnton, NC, is seeking a QA/QC Documentation Auditor to review laboratory records, ensure data integrity, and support regulatory compliance in the Quality Control Department.

The role involves approving raw materials, finished products, and stability data, tracking deviations, and maintaining documentation according to FDA guidance and GDPs, with emphasis on accuracy and timely reporting.