Quality Assurance Representative
Elanco
Full-time
Remote friendly (Clinton, IN)
United States
Operations
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Role Summary
Quality Assurance Representative working to support Clinton Manufacturing Operations, ensuring quality systems adhere to Good Manufacturing Practices (GMP). Facilitate compliance, support continuous improvement initiatives, and provide guidance to operational staff.
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.
Qualifications
- Education: Bachelor’s Degree or equivalent experience in a science-related field.
- Required Experience: A minimum of 5 years of experience in cGMP within pharmaceutical manufacturing, or relevant life sciences experience.
- Top Skills: 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.
Skills
- Quality systems management
- Batch record review
- Deviation investigations
- Change control
- SAP for quality and manufacturing documentation
- Regulatory compliance (cGMP)
Education
- Bachelor’s Degree in a science-related field (or equivalent experience)
Additional Requirements
- Location: Clinton, Indiana Manufacturing Site