Senior Associate-Quality Assurance

As aSeniorQA 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 byproviding assistanceand 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 validationandPQR.

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-KG2

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

Elanco 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.