Senior Associate-Quality Assurance

Elanco Tiergesundheit AG; Michigan; On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Relocation packages

2 weeklong shutdowns (US)

8-week parental leave

Employee Resource Groups

Job summary

Elanco is seeking a Senior QA Representative to join the Clinton Quality Control Unit. You will support quality systems, investigations, and continuous improvement while ensuring GMP compliance and inspection readiness.

Responsibilities include assisting with PQRs, method validation, and change control, while collaborating with QC technicians, chemists, and analysts to uphold quality standards across production.

Qualifications

• Bachelor’s degree in a related scientific field.
• 2+ years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environment.
• Proficiency in cGMP regulations and quality documentation systems.

Responsibilities

• Provide QC support in investigations, PQR, and method validation.
• Maintain GMP compliance and inspection readiness through audits and inspections.
• Lead deviation investigations and implement change control proposals.

Skills

Quality Assurance

GMP Compliance

Documentation Systems

Education

Bachelor’s degree in Chemistry, Biology, Pharmacy

Job description

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 AssuranceAs 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 fieldExperience: A minimum of 2 years of experience in Quality Assurance, Quality Control, or a regulated GMP manufacturing environmentTop Skills: Proficiency in cGMP regulations and experience with quality documentation systemsWhat Will Give You a Competitive Edge (preferred qualifications):Experience coaching or providing technical feedback to QC staffProven ability to handle non-standard requests and participate in regulatory auditsStrong technical writing skills for authoring validation and PQR documentsExperience with change control implementation and deviation managementDemonstrated ability to work effectively in cross-functional team environmentsAdditional Information:Location: Clinton, IN – Onsite Manufacturing FacilityDon’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 packagesTwo weeklong shutdowns (mid-summer and year-end) in the US (in addition to PTO)8-week parental leave9 Employee Resource GroupsAnnual bonus offeringUp 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.