Quality Assurance Associate – Manufacturing Floor (Evening & Night Shift)

Elanco Tiergesundheit AG; Elwood (KS); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Relocation packages

Parental leave

Annual bonus

401K matching

Onsite facilities

Job summary

Elanco is seeking a Quality Assurance Associate for the Manufacturing Floor at our Elwood, KS site. You will coordinate QA activities on the floor, observe production processes, and act as first responder for manufacturing issues while championing regulatory compliance.

You will review documents, approve batch records and change controls, and participate in investigations and CAPA closure. The role requires a Life Science degree and GMP knowledge, with the ability to work in clean room

Qualifications

• BA/BS (or Master’s) in Life Science preferred, and/or 3 years’ experience in regulated industry.
• Direct experience with Quality Assurance in regulated industry (USDA, FDA, ISO).
• Knowledge of GMP principles and global drug manufacturing regulations.

Responsibilities

• Interact with Manufacturing to champion compliance and provide quality floor support.
• Review and approve controlled documents (batch records, logbooks, solution records).
• Review change management, deviations, investigations and CAPA; write and revise QA documents.
• Assist QA projects with minimal supervision and support QA team.

Skills

Quality Assurance

GMP

Regulated Industry

Problem Solving

Team Collaboration

Education

B.S./B.A. in Life Science

Master's in Life Science

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!Job DescriptionYour Role: Quality Assurance Associate – Manufacturing FloorThis position coordinates and conducts activities of the Quality Assurance Department regarding manufacturing floor support and has specific responsibilities for other quality and compliance related activities as directed by the Quality Assurance Manager. This position plays a key role in day-to-day operations and works very closely with the Manufacturing and Process Teams.Your Responsibilities:Actively interact with Manufacturing and champion compliance through leadership and example in daily processes. Provide quality floor support, including observing daily active processes for: statuses, issues, concerns, and issuance of cell banks. Act as first responder for manufacturing activities and represent QA on cross-functional process teams.Identify, investigate, and resolve complex technical issues using problem-solving skills. Participate in investigation teams, determine next steps and assist in the proper close out and follow up actions. Make decisions independently and notify management of actions taken.Perform QA review/approval of controlled documents including, but not limited to, solution records, batch records, logbooks, autoclave cycles with a high attention to detail, using extensive working knowledge of quality concepts and internal procedures and controls.Review change management documentation, deviations, investigations and CAPA records for completion. Write new documents and revise existing QA documents as needed.Participate and manage QA projects as needed with minimal supervision. Receive overall project direction from management but complete most work independently. Assist other Quality Assurance Associate(s) and Quality Assurance Manager(s) as needed.What You Need to Succeed (Minimum Qualifications):BA/BS (or Master's) in any Life Science discipline preferred, and/or 3 years’ experience in regulated industry (USDA, FDA, ISO etc).Must have direct experience with Quality Assurance within regulated industry (USDA, FDA, ISO, etc.)Understands and applies comprehensive knowledge of quality and GMP principles and maintains current understanding of global GMP drug manufacturing regulations.Must be able to work in controlled / clean room environments requiring gowning qualifications.What Will Give You the Competitive Edge (Preferred Qualifications):Familiarity with basic statistics, review/approval of documentation; risk tools, technical writing, and writing/reviewing/approving investigations.Ability to handle multiple tasks and competing priorities concurrently and in a timely fashion.Good interpersonal skills and ability to work effectively and efficiently in a team environment to accomplish goals.Demonstrated experience making sound independent decisions.Additional InformationLocation: Elwood, KS Manufacturing SiteMust be able to work in controlled / clean room environments requiring gowning qualifications.Evening Shift: 4:00pm - 12:30am & Night Shift: 12am - 8:30am, Monday - FridayRotating weekend schedule required (every 3rd weekend) 24/7 hr. siteDon’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 packages8-week parental leave9 Employee Resource GroupsAnnual bonus offeringUp to 6% 401K matching#LI-HL#LI-OnsiteElanco 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.