Elanco is looking to solve the problem of ensuring quality systems adhere to Good Manufacturing Practices (GMP) in their Clinton Manufacturing Operations
Requirements
- Strong knowledge and application of cGMP principles in pharmaceutical or regulated manufacturing environments
- Proficiency in quality systems processes, including batch record review, deviation investigations, change control, and use of SAP for quality and manufacturing documentation
- Experience with deviation investigations and change control processes
- Knowledge of industry regulations and compliance standards
- Experience using SAP in a GMP setting for quality and manufacturing operations
- CSQA certification or demonstrated understanding of CSQA principles
Responsibilities
- Provide production floor quality support by assisting with procedures, master batch records, and quality system monitoring, while ensuring GMP compliance and readiness for regulatory inspections
- Review and approve batch records and support batch release processes in alignment with internal procedures and regulatory requirements, utilizing SAP for documentation, materials management, and quality-related transactions
- Drive continuous improvement initiatives by coaching and supporting deviation investigations, change control proposals, and enhancements to quality systems and processes
- Collaborate with leadership and cross-functional teams to identify, implement, and verify improvements through self-inspections, internal audits, and other compliance assessments
- Provide guidance and feedback to operational staff on quality expectations, data integrity, and computer system validation principles, ensuring adherence to CSQA standards
Other
- Bachelor’s Degree or equivalent experience in a science-related field
- A minimum of 5 years of experience in cGMP within pharmaceutical manufacturing, or relevant life sciences experience
- Proven ability to prioritize and manage multiple tasks effectively
- Ability to work in a team environment and collaborate with cross-functional teams
- 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
