Senior Associate-Quality Assurance

Elanco; Clinton (IN); Híbrido; USD 65.000 - 90.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Relocation packages

Shutdowns

Parental leave

Annual bonus

401K matching

Employee Resource Groups

Descripción de la vacante

Elanco Tiergesundheit AG in Clinton, IN, is seeking a Senior Associate in Quality Assurance to support GMP compliance and quality systems. You will drive investigations, method validation, and continuous improvement within the Clinton QC Unit, partnering with chemists, analysts, and technicians to maintain inspection readiness.

Ideal candidates have a Bachelor’s in a scientific field and at least 2 years of QA/QC experience in a regulated manufacturing environment, with strong knowledge of cGMP

Formación

• Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field.
• Minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment.
• Strong knowledge of cGMP regulations and quality documentation systems.

Responsabilidades

• Provide QC support by assisting in laboratory investigations, PQR, and method validation activities.
• Maintain GMP compliance and inspection readiness through audits and inspections of production areas.
• Facilitate continuous improvement by authoring and supporting deviation investigations and change control proposals.
• Collaborate across cross-functional QC teams to ensure quality standards.
• Investigate customer complaints and review critical quality documents including validation and PQR.
• Support and strengthen site Quality Systems by writing and revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums.

Conocimientos

Proficiency in cGMP regulations

Experience with quality documentation

Educación

Bachelor’s degree in Chemistry, Biology, Pharmacy, or related field

Descripción del empleo

## Senior Associate-Quality AssuranceApplylocations: Clinton, INtime type: Full timeposted on: Posted Todayjob requisition id: R0026668**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.** **At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People.****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: Senior Associate – Quality Assurance**As a Senior QA Representative, you will be part of the Clinton Quality Control Unit to deliver essential support for quality systems and GMP compliance. In this role, you’ll be responsible for advancing laboratory investigations, method validation, and continuous improvement initiatives through coaching and change control implementation.**Your Responsibilities:*** Provide quality control support by providing assistance and guidance in laboratory investigations, Product Quality Reviews (PQR), and method validation activities.* Maintain GMP compliance and inspection readiness for regulatory agencies through periodic audits and inspections of production areas.* Facilitate continuous improvement by authoring and supporting deviation investigations and implementing change control proposals.* Collaborate effectively across cross-functional QC teams, including laboratory technicians, chemists, and analysts, to ensure quality standards.* Investigate customer complaints and review critical quality documents, including validation and PQR.* Support and strengthen site Quality Systems by writing and revising SOPs, delivering site training, conducting internal audits, verifying inspection readiness, monitoring quality metrics, and representing the site in corporate knowledge-sharing forums.**What You Need to Succeed (minimum qualifications):*** **Education:** Bachelor’s degree in Chemistry, Biology, Pharmacy, or a related scientific field* **Experience:** A minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment* **Top Skills:** Proficiency in cGMP regulations and experience with quality documentation systems**What Will Give You a Competitive Edge (preferred qualifications):*** Experience coaching or providing technical feedback to QC staff* Proven ability to handle non-standard requests and participate in regulatory audits* Strong technical writing skills for authoring validation and PQR documents* Experience with change control implementation and deviation management* Demonstrated ability to work effectively in cross-functional team environments**Additional Information:*** **Location:** Clinton, IN – Onsite Manufacturing Facility***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#LI-KG2Elanco 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 statusElanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‐related criteria and/or transferrable skills. These tools help ensure a consistent, structured evaluation, but they do not make hiring decisions. All decisions involve a human reviewer. For more information on how we handle personal data, please see our Elanco Workforce Privacy Notice.