Quality Assurance Associate: GMP Release & Compliance

Elanco; Fort Dodge (IA); On-site; USD 55,000 - 75,000; Full time

Job summary

Elanco is seeking a Quality Associate to provide critical QA support for the Release Group and Process Team. You will review developmental and revised batch records and ensure compliance with USDA, FDA, and EU regulations.

This role includes on-the-floor QA guidance, deviation investigations, and support for audits. This entry-level to mid-level QA position requires a scientific degree or equivalent experience, attention to detail, and proficiency with SAP and Veeva.

Qualifications

• GMP-regulated environment experience
• Documentation review of batch records and quality systems
• Strong attention to detail and accuracy
• Proficiency with SAP and Veeva systems
• Experience with SOPs and quality investigations
• Good written and oral communication

Responsibilities

• Review and approve batch records and technical documentation for compliance.
• Provide on-the-floor QA support to production and QA Release groups.
• Assist with deviation investigations and CAPAs.
• Support audits and regulatory inspections as needed.
• Execute release decisions in SAP for product movement.

Job description

Elanco is seeking a Quality Associate to provide critical QA support for the Release Group and Process Team. You will review developmental and revised batch records and ensure compliance with USDA, FDA, and EU regulations.

This role includes on-the-floor QA guidance, deviation investigations, and support for audits. This entry-level to mid-level QA position requires a scientific degree or equivalent experience, attention to detail, and proficiency with SAP and Veeva.