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Sr. Associate, Quality Assurance Validation at Elanco - ApplyBlast

Sr. Associate, Quality Assurance Validation

Elanco

4 months ago

4.0 on Glassdoor

Elwood, KS

Onsite

Full Time

Senior

0 applicants

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About this role

The Senior Associate, Quality Assurance Validation role at Elanco supports capital projects, commissioning, and computer system validation activities at a monoclonal antibody manufacturing facility. This position serves as a key quality representative to ensure facilities, utilities, and systems comply with regulatory requirements, focusing on data integrity and cGMP standards. The candidate partners with engineering and cross-functional teams to oversee the full lifecycle of equipment and system qualifications.

Responsibilities

Provide Quality oversight for capital projects from design through qualification
Review and approve validation lifecycle documentation including protocols and reports
Support and oversee computer system validation activities maintaining data integrity
Ensure compliance with cGMP and regulatory requirements for site operations
Support internal audits and regulatory inspections across all activities

Skills

Qualifications

Bachelor’s degree in science or engineering5+ years experience in quality, engineering, or validationExperience in biologics or pharmaceutical industryProficiency with Microsoft Office SuitePreferred knowledge of USDA, FDA, or EMA regulations

About Elanco

elanco.com

Headquarters

Indianapolis, Indiana, United States

Company Size

5001-10000 employees

Founded

1954

View Profile

As a global leader in animal health, Elanco provides innovative solutions to improve animal health and wellbeing for both farm animals and pets. For more than 70 years, Elanco has empowered veterinarians, farmers, and animal health professionals to transform animal care. Making life better for animals, makes life better.