On-the-Floor Quality Assurance Associate (2nd Shift)

Elanco; Fort Dodge (IA); Presencial; USD 55.000 - 75.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Two weeklong shutdowns

8-week parental leave

Employee Resource Groups

Annual bonus up to 6%

401K matching

Descripción de la vacante

Elanco Animal Health Incorporated is seeking a Quality Assurance Associate for the On the Floor shift (2nd shift 2PM-10:00PM). The role focuses on reviewing batch records, ensuring regulatory compliance, and driving continuous improvement in production processes.

The candidate will verify documentation, contribute to CAPA investigations, and train team members while adhering to USDA/FDA requirements and company procedures.

Formación

• Associate's Degree in a science-related field and relevant industry experience or a Bachelor's Degree in a science-related field (Biology, Chemistry, etc.).
• Previous experience with USDA/FDA regulatory requirements in a biological production environment.
• Previous experience utilizing computer programs such as Microsoft suite, SAP, Veeva, Learning One Source and other relevant electronic applications.

Responsabilidades

• Review and approve product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).
• Track/report/and define continuous improvement goals, determine root cause for deviation/CAPA reports, and subsequent communication back to the Process Team.
• Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.
• Develops training plans and trains/qualifies others, including training outside of area of responsibility.
• Demonstrates understanding of regulations for various countries and provides input or approval accordingly.

Conocimientos

Regulatory experience

Documentation

Quality systems

Educación

Associate's degree in science

Bachelor's degree in science

Herramientas

Microsoft Suite

SAP

Veeva

Learning One Source

Descripción del empleo

Elanco Animal Health Incorporated is seeking a Quality Assurance Associate for the On the Floor shift (2nd shift 2PM-10:00PM). The role focuses on reviewing batch records, ensuring regulatory compliance, and driving continuous improvement in production processes.

The candidate will verify documentation, contribute to CAPA investigations, and train team members while adhering to USDA/FDA requirements and company procedures.