At Elanco, the business problem is to ensure that all products meet the required specifications and regulatory requirements, such as USDA and GMP, to advance the health of animals, people, and the planet.
Requirements
- Knowledge of pharmaceutical cGMPs (US and EU), FDA, USDA, VICH, and EU as related to manufacturing, quality, and release activities.
- Technically self-sufficient and proficient in the performance of batch audits, product release, understanding of 9CFR and Form 2008 USDA submissions.
- Demonstrated experience and proficiency with SAP, Veeva Vault, Microsoft Office (Word, Excel, PowerPoint, and Outlook).
- 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.
- Understanding of quality concepts and internal procedures/controls.
- Extensive working knowledge of quality concepts and internal procedures/controls.
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.
- 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.
Other
- Bachelor’s degree in a scientific discipline (preferred) with 3+ years of quality experience.
- Strong leadership, team building, organizational and interpersonal skills.
- Excellent written and verbal communication skills with internal and external customers, peers, and managers.
- Excellent technical writing skills.
- Ability to work with minimal supervision.
