As a leading global animal health company, Elanco delivers innovative products and services to improve the health of pets and farm animals around the world because we believe making animals' lives better, makes life better. Since 1954, we have provided solutions that support veterinarians, farmers and pet owners to advance our vision of Food and Companionship Enriching Life. Elanco's promise to employees: Together, we foster an inclusive culture where everyone can make a difference, encouraging ownership, growth and well-being.

Position Description:

The QA Associate, Product Release reports directly to the QA Manager. This individual will be responsible for auditing products for final disposition for the Elanco Elwood, KS 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.

Functions, Duties, Tasks:

• Perform batch record review, status notifications, assignment of stickering, and serial file reviews for in-process or product release.
• Responsible for control of official batch related records into and out of QA Department.
• Perform batch audits and final disposition for manufactured products for compliance to GMP/Outline.
• Perform review and approval of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing).
• Review and approve Certificates of Analysis and Certificates of Compliance for batch release.
• Perform Impact assessments on products to comply with USDA or other GMP regulatory requirements.
• Review and/or approve local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production.
• Prepare, Review and/or Submit APHIS Form 2008’s against applicable Outlines of Production for USDA release.
• Ensure product documentation is complete and compliant with specifications, SOPs, and regulations.
• 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 to solve quality related issues.
• Assist with internal, regulatory, and corporate audits to ensure compliance with regulations, quality standards and guidance documents.
• Assist with audit responses and completion of assigned CAPAs by target due dates.
• Lead, mentor, and coach operations and support personnel on quality and good documentation matters
• Other duties as assigned.

Basic Minimum Qualifications:

• Bachelor’s degree in a scientific discipline (preferred) with 3+ years of quality experience.
• Technically self-sufficient and proficient in the performance of batch audits, product release, understanding of 9CFR and Form 2008 USDA submissions.
• Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities.
• Must be able to utilize all elements of the quality system to identify, classify, and control the status of finished products produced.
• Strong leadership, team building, organizational and interpersonal skills. High attention to detail.
• Knowledge and understanding of biopharmaceutical and pharmaceutical operations.
• Analytical Skills: Highly analytical and strong advocate for process improvement.
• Excellent written and verbal communication skills with internal and external customers, peers, and managers.
• Excellent computer, documentation, and organizational skills required.
• Demonstrated ability to work collaboratively and across multiple departments and organization levels. Experience with Microsoft Office (Microsoft Word, Excel, PowerPoint, and Outlook).
• Qualified candidates must be legally authorized to be employed in the United States. Elanco does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.

Additional Preferences:

• Experience in Operational Excellence and/or Investigation procedures.
• Experience in Materials Management for USDA or FDA regulated industries.
• Experience in Quality Control testing and environments.
• 5+ years’ experience in the Biotech / Pharmaceutical industry.
• Experience in tech transfer, optimization, and validation of analytical methods for characterization of biological products (e.g., mAbs, recombinant proteins, vaccines).
• Experience with SAP and Veeva Vault.
• Excellent technical writing skills.
• Working knowledge of VICH, USDA and/or EU GMP regulations for veterinary biologics.

Other Information:

• This is a full-time permanent salaried position.
• This is considered an on-site position.
• Day shift position. Weekend and evening work not usual, although may be required to provide process support to ongoing operations.
• Minimal travel requirements < 5%.

Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status