Quality Compliance Assistant - cGMP & QA Support

Amneal Pharmaceuticals; Glasgow (KY); On-site; USD 32,000 - 46,000; Full time

Job summary

Amneal Pharmaceuticals is seeking a Quality Management Assistant to support quality systems and regulatory compliance within a pharmaceutical distribution center. You will assist with batch documentation, inventory classification, and customer returns processing to maintain product quality and patient safety.

Essential duties include supporting QA activities, environmental monitoring, and audit preparation while ensuring adherence to SOPs and FDA regulations in a fast-paced distribution

Qualifications

• - High School or GED is required.
• - Familiarity with FDA regulations relates to OTC/Prescription products.
• - Knowledge of cGMP is required.
• - Must be able to read and write in English.

Responsibilities

• Assist with preparation and review of Batch Documents (COA, COC, Serialization, temp/humidity data).
• Support customer returns process per SOP and ensure proper disposition.
• Maintain inventory status across Hold/Quarantine/Released/Morgue in the distribution center.
• Support shipping studies to ensure product integrity during distribution.
• Assist ad hoc sampling per SOPs and cGMP requirements.
• Issue controlled forms and logbooks to stakeholders with proper documentation and traceability.
• Assist audits by preparing, participating, and reviewing documentation.
• Perform other duties to support quality systems and regulatory compliance.

Skills

English proficiency

Microsoft Office

Education

High School or GED

Tools

Microsoft Office

Job description

Amneal Pharmaceuticals is seeking a Quality Management Assistant to support quality systems and regulatory compliance within a pharmaceutical distribution center. You will assist with batch documentation, inventory classification, and customer returns processing to maintain product quality and patient safety.

Essential duties include supporting QA activities, environmental monitoring, and audit preparation while ensuring adherence to SOPs and FDA regulations in a fast-paced distribution