Your Role: Quality Assurance Specialist

As a Quality Assurance Specialist, you will play a crucial role in supporting Clinton Manufacturing Operations and ensuring that quality systems adhere to Good Manufacturing Practices (GMP). In this position, you'll be responsible for facilitating compliance, supporting continuous improvement initiatives, and providing guidance to operational staff.

Your 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.

What You Need to Succeed (minimum 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.

What will give you a competitive edge (preferred qualifications):

• Experience in Quality Assurance, Quality Control, or Manufacturing in a regulated environment.

• Proven ability to prioritize and manage multiple tasks effectively.

• 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.

Additional Information:

• Location: Clinton, Indiana Manufacturing Site

Don't meet every single requirement? Studies have shown underrepresented groups are less likely to apply to jobs unless they meet every single qualification. At Elanco we are dedicated to building a diverse and inclusive work environment. If you think you might be a good fit for a role but don't necessarily meet every requirement, we encourage you to apply. You may be the right candidate for this role or other roles!

Elanco Benefits and Perks:

We offer a comprehensive benefits package focusing on financial, physical, and mental well-being while encouraging our employees to pursue our purpose! Some highlights include:

• Multiple relocation packages

• Two weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)

• 8-week parental leave

• 9 Employee Resource Groups

• Annual bonus offering

• Up to 6% 401K matching