On-the-Floor QA Specialist: GMP & Process Improvement

Elanco Tiergesundheit AG; Fort Dodge (IA); On-site; USD 52,000 - 70,000; Full time

Benefits offered by this job

Relocation packages

Two weeklong shutdowns (mid-summer and

year-end) in the US

8-week parental leave

Annual bonus offering

Up to 6% 401K matching

Job summary

Elanco is hiring a Quality Assurance Associate on the floor (OTF) for the 2nd shift (2PM-10PM) in Fort Dodge, IA. The role supports Process Teams by reviewing batch records, investigating deviations, and driving CAPA actions.

You will train staff, audit processes for GMP/GDP compliance, and coordinate with Process Team Lead and Quality Lead. Requirements include an associate or bachelor degree in a science field, plus experience with USDA/FDA rules in biotech production and proficiency with MS

Qualifications

• Associate degree in science with relevant experience or a B.S. in science.
• Experience with USDA/FDA regulatory requirements in biological production.
• Proficient with MS Office, SAP, Veeva or related systems.

Responsibilities

• Review and approve batch records and related documentation.
• Track and report continuous improvement goals; root-cause analysis for deviations.
• Audit production processes for compliance and update procedures as needed.
• Develop and deliver training plans for staff in GMP/GDP practices.
• Ensure regulatory understandings for different countries are implemented.

Education

Associate's Degree in a science-related field

Bachelor's Degree in a science-related field

Tools

Microsoft Suite

SAP

Veeva

Learning One Source

Job description

Elanco is hiring a Quality Assurance Associate on the floor (OTF) for the 2nd shift (2PM-10PM) in Fort Dodge, IA. The role supports Process Teams by reviewing batch records, investigating deviations, and driving CAPA actions.

You will train staff, audit processes for GMP/GDP compliance, and coordinate with Process Team Lead and Quality Lead. Requirements include an associate or bachelor degree in a science field, plus experience with USDA/FDA rules in biotech production and proficiency with MS