GMP QA Specialist – Manufacturing Floor

Farmer Veteran Coalition

Kansas

On-site

USD 60,000 - 85,000

Full time

7 days ago
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Benefits offered by this job

Relocation packages
Parental leave
Employee Resource Groups
Annual bonus
401K matching

Job summary

Elanco is seeking a Quality Assurance Associate for the Manufacturing Floor in Elwood, KS. You will support day-to-day QA activities on the floor, review documents, and collaborate with Manufacturing and Process teams to ensure compliance with GMP standards.

The role requires a Life Science degree and demonstrated QA experience in regulated environments, with gowning in clean rooms. Night shifts and weekend coverage may be required; relocation options are available for the right candidate.

Qualifications

  • BA/BS in Life Science or Master’s preferred with 3 years in regulated industry.
  • Direct QA experience in USDA/FDA/ISO or similar environments.
  • GMP principles and global drug regulations understood.
  • Ability to work in controlled/clean room environments with gowning.

Responsibilities

  • Interact with Manufacturing to champion compliance in daily processes.
  • Provide floor QA support by observing active processes and issues.
  • Represent QA on cross-functional process teams.
  • Investigate and resolve complex technical issues.
  • Participate in investigation teams and follow-up actions.
  • Review and approve controlled documents (batch records, logbooks, etc.).
  • Review change management docs, deviations, CAPA records.
  • Write and revise QA documents as needed.
  • Lead QA projects with minimal supervision.
  • Receive direction from management and complete work independently.
  • Support other QA staff as needed.

Skills

QA experience
GMP knowledge
Regulated industry
Clean room work

Education

BA/BS in Life Science
Master's in Life Science

Job description

Elanco is seeking a Quality Assurance Associate for the Manufacturing Floor in Elwood, KS. You will support day-to-day QA activities on the floor, review documents, and collaborate with Manufacturing and Process teams to ensure compliance with GMP standards.

The role requires a Life Science degree and demonstrated QA experience in regulated environments, with gowning in clean rooms. Night shifts and weekend coverage may be required; relocation options are available for the right candidate.

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