Quality Assurance Associate-1
Elanco
9 hours ago
Remote friendly (Fort Dodge, IA)
United States
Operations
Quality Associate – QA Release
Responsibilities:
- Review and approve product batch records and supporting documentation to ensure compliance with cGMP and regulatory requirements (USDA, FDA, EU, etc.)
- Initiate, assess, and support deviation investigations, including participation in root cause analysis and corrective actions
- Perform SAP usage decisions and release transactions to support product movement and final product disposition
- Support internal and external regulatory inspections while maintaining audit readiness
- Partner cross-functionally with Operations, TSMS, Engineering, QC, and Logistics to improve quality systems and reduce compliance risk
Minimum Qualifications:
- Education: Associate degree or High School Diploma/GED with equivalent experience preferred
- Experience: 2+ years in a Quality-related role, preferably within pharmaceutical, healthcare, or other regulated manufacturing environments
- Skills: Strong attention to detail and quality mindset; excellent communication; proficiency with Microsoft Office, SAP, and Veeva (or similar platforms)
Preferred Qualifications:
- Experience in cGMP-regulated manufacturing
- Experience reviewing batch records, deviations, and technical documentation
- Familiarity with USDA, FDA, and EU regulatory requirements
- Experience participating in Lean, Six Sigma, or Operational Excellence initiatives
- Demonstrated ability to collaborate across Quality, Manufacturing, Engineering, and technical teams
Responsibilities:
- Review and approve product batch records and supporting documentation to ensure compliance with cGMP and regulatory requirements (USDA, FDA, EU, etc.)
- Initiate, assess, and support deviation investigations, including participation in root cause analysis and corrective actions
- Perform SAP usage decisions and release transactions to support product movement and final product disposition
- Support internal and external regulatory inspections while maintaining audit readiness
- Partner cross-functionally with Operations, TSMS, Engineering, QC, and Logistics to improve quality systems and reduce compliance risk
Minimum Qualifications:
- Education: Associate degree or High School Diploma/GED with equivalent experience preferred
- Experience: 2+ years in a Quality-related role, preferably within pharmaceutical, healthcare, or other regulated manufacturing environments
- Skills: Strong attention to detail and quality mindset; excellent communication; proficiency with Microsoft Office, SAP, and Veeva (or similar platforms)
Preferred Qualifications:
- Experience in cGMP-regulated manufacturing
- Experience reviewing batch records, deviations, and technical documentation
- Familiarity with USDA, FDA, and EU regulatory requirements
- Experience participating in Lean, Six Sigma, or Operational Excellence initiatives
- Demonstrated ability to collaborate across Quality, Manufacturing, Engineering, and technical teams