Pharma QC Auditor - GMP Compliance & Data Integrity

cosettepharma; Lincolnton (NC); On-site; USD 60,000 - 80,000; Full time

Job summary

Cosette Pharmaceuticals, a US-based manufacturing site, is seeking a QA/QC Auditor to review QA/QC documentation and assess data compliance with regulatory guidelines in the Quality Control Department. The role focuses on releasing materials and data integrity, with emphasis on GDPs and cGMPs.

The candidate will audit data, track deviations and investigations, and maintain training tools for Auditor I, ensuring timely and accurate documentation in a fast-paced laboratory setting.

Qualifications

• BS or BA in Chemistry or related science with one year of regulated environment auditing experience (FDA, GLP, etc).
• Familiarity with FDA regulations (cGMP, GDPs, USP/BP) as pertains to QC Laboratory.
• Ability to read and interpret technical documentation (Monographs, GTMs, USP/BP Test Methods).
• Proficient in mathematics and data interpretation; attention to detail required.

Responsibilities

• Provide technical support for release of raw materials, finished products, and stability data.
• Review all recorded QC data for compliance to test methods, GDPs, and internal SOPs.
• Track and assist in resolution/closure of deviations, invalidations, out of trend reports, and out of specification investigations.
• Track and complete Training Guidelines and Training Effectiveness Tools for Auditor I.
• Audit laboratory documentation for accuracy, legibility, and completeness.
• Other duties as assigned by management

Skills

Documentation auditing

Regulatory compliance

Data interpretation

General chemistry

Mathematics proficiency

Reading technical docs

Education

BS/BA in Chemistry or related science

Tools

Empower

USP

Job description

Cosette Pharmaceuticals, a US-based manufacturing site, is seeking a QA/QC Auditor to review QA/QC documentation and assess data compliance with regulatory guidelines in the Quality Control Department. The role focuses on releasing materials and data integrity, with emphasis on GDPs and cGMPs.

The candidate will audit data, track deviations and investigations, and maintain training tools for Auditor I, ensuring timely and accurate documentation in a fast-paced laboratory setting.