Manufacturing Floor Quality Assurance Specialist

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Annual bonus

401K matching

Onsite facilities

Job summary

Elanco is seeking a Quality Assurance Associate for the Manufacturing Floor at our Elwood, KS site. You will coordinate QA activities on the floor, observe production processes, and act as first responder for manufacturing issues while championing regulatory compliance.

You will review documents, approve batch records and change controls, and participate in investigations and CAPA closure. The role requires a Life Science degree and GMP knowledge, with the ability to work in clean room

Qualifications

• BA/BS (or Master’s) in Life Science preferred, and/or 3 years’ experience in regulated industry.
• Direct experience with Quality Assurance in regulated industry (USDA, FDA, ISO).
• Knowledge of GMP principles and global drug manufacturing regulations.

Responsibilities

• Interact with Manufacturing to champion compliance and provide quality floor support.
• Review and approve controlled documents (batch records, logbooks, solution records).
• Review change management, deviations, investigations and CAPA; write and revise QA documents.
• Assist QA projects with minimal supervision and support QA team.

Skills

Quality Assurance

GMP

Regulated Industry

Problem Solving

Team Collaboration

Education

B.S./B.A. in Life Science

Master's in Life Science

Job description

Elanco is seeking a Quality Assurance Associate for the Manufacturing Floor at our Elwood, KS site. You will coordinate QA activities on the floor, observe production processes, and act as first responder for manufacturing issues while championing regulatory compliance.

You will review documents, approve batch records and change controls, and participate in investigations and CAPA closure. The role requires a Life Science degree and GMP knowledge, with the ability to work in clean room