On-the-Floor QA Associate, 2nd Shift — Drive Quality

Elanco; Fort Dodge (IA); Hybrid; USD 52,000 - 68,000; Full time

Benefits offered by this job

Relocation packages

Annual bonus

401K matching

Parental leave

Job summary

Elanco in the United States is seeking a Quality Assurance Associate for the on-the-floor role on the 2nd shift (2PM-10:00PM). You will support Process Teams by reviewing batch records, identifying deviations, and writing investigation reports.

You will audit processes for GMP/GDP compliance, train staff, and collaborate with the Process Team Lead and Quality Lead to drive continuous improvement across site operations.

Qualifications

• Review and approve product batch records and related documentation.
• Track and define continuous improvement goals; identify root causes for deviations.
• Audit production processes for compliance and update procedures accordingly.
• Develop training plans and train/qualify others, including cross-area training.
• Demonstrate understanding of country regulations and provide input as needed.

Responsibilities

• 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.

Skills

Attention to detail

Decision making

Customer communication

Idea generation

Education

Associate's Degree in a science-related field

Bachelor's Degree in a science-related field

Tools

SAP

Veeva

Learning One Source

Microsoft Office

Job description

Elanco in the United States is seeking a Quality Assurance Associate for the on-the-floor role on the 2nd shift (2PM-10:00PM). You will support Process Teams by reviewing batch records, identifying deviations, and writing investigation reports.

You will audit processes for GMP/GDP compliance, train staff, and collaborate with the Process Team Lead and Quality Lead to drive continuous improvement across site operations.