Quality Assurance Associate - Product Release

Elanco•Elwood, KS

14d

About The Position

At Elanco (NYSE: ELAN) – it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise. At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights. Making animals’ lives better makes life better – join our team today! Your Role: Quality Assurance Associate – Product Release The QA Associate - Product Release, reports directly to the QA Manager. This position 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.

Requirements

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.

Nice To Haves

Strong leadership, team building, organizational and interpersonal skills.
High attention to detail.
Demonstrated experience and proficiency with SAP, Veeva Vault, Microsoft Office (Word, Excel, PowerPoint, and Outlook).
Excellent written and verbal communication skills with internal and external customers, peers, and managers.
Excellent technical writing skills.
Experience in quality and manufacturing of biological products (e.g., mAbs, recombinant proteins, vaccines).
Experience in Operational Excellence, investigation procedures, materials management, and/or quality control testing for USDA or EU GMP regulated industries.

Responsibilities

Perform batch record review and audits, status notifications, assignment of stickering, serial file reviews and final disposition for manufactured in-process or final product release to ensure compliance to cGMPs/Outlines/Standards.
Perform QA review/approval of executed records (Batch Records, Manufacturing Directions, Solution Records, Autoclave Records, Logbooks, QC Testing), Certificates of Analysis/Compliance for batch release. and local SOPs, Test Specifications, Master Production Record Review, Special Outlines and Outlines of Production with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures/controls.
Ensure product documentation is complete and compliant with specifications, SOPs, and regulations.
Prepare, review and/or submit APHIS Form 2008’s against applicable Outlines of Production for USDA release.
Review change management documentation, deviations, investigations and CAPA records for completion.
Write new documents and revise existing QA documents as needed.
Participate in and manage QA projects as needed with minimal supervision. Receive overall project direction from management but complete most work independently.
Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.