Quality Assurance Associate - Batch Release - Elanco

Your Role: Quality Assurance Associate - Batch Release

This individual will be responsible for auditing products for final disposition for the Elanco Fort Dodge site. This position assures that all specifications and Outline of Production requirements are met prior to each stage of release leading up to Form 2008 submissions to comply with USDA, and GMP regulatory requirements. The scope of the support includes every state of manufacturing including products for 3rd party Contract Manufacturing.

Your Responsibilities:  

• Perform batch audits and final disposition for manufactured products for compliance to GMP, perform review and approval of executed batch records and/or test records, perform Impact assessments on products to comply with USDA or other GMP regulatory requirements, and perform form review and approval of APHIS Form 2008’s against applicable Outlines of Production for USDA 
  release.

• Review and approve Certificates of Analysis and Certificates of Compliance for batch release, review technical investigation reports, reference requalification, and optimization studies detailing findings, and review and approve local SOPs, Test Specifications, QC Methods, Special Outlines and Outline of Production.

• Create CBRs/International permits for international release 
  and product assessments.

• Ensure product documentation is complete and compliant with specifications, SOPs and regulations as well as submits product release data for monthly KPI and Metric reports.

• Serve as a QA representative and SME on assigned internal and external project/process flow teams, assist with audits to ensure compliance, and assist with audit responses and completion of assigned CAPAs by target due dates.

What You Need to Succeed (minimum qualifications): 

• Bachelor’s degree or equivalent level of experience

• Technically self-sufficient and proficient in the performance of batch audits and intermediate product release

What will give you a competitive edge (preferred qualifications): 

• Understanding of 9CFR and Form 2008 USDA submissions

• Good understanding of the relevant USDA regulations.

• Proficiency in relevant computer software programs associated with the area (Microsoft Suite, SAP, VEEVA, etc.)

• Ability to select, develop and assess the appropriateness of regulated processes and technical disciplines associated with the manufacture, testing, and verification of products manufactured by Elanco.

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Additional Information:  

• Location: Fort Dodge, IA

Don’t meet every single requirement? Studies have shown underrecognizedgroups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!  

Elanco Benefits and Perks: 

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include: 

• Multiple relocation packages for eligible positions

• Two weeklongshutdowns (mid-summer and year-end) in the US (in addition to PTO) 

• 8-week parental leave 

• 9 Employee Resource Groups 

• Annual bonus offering 

• Flexible work arrangements 

• Up to 6% 401K matching