Quality Assurance Associate, On the Floor (OTF) (Information Technology)
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. We're driven by our vision of ‘Food and Companionship Enriching Life' and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
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: Quality Assurance Associate, On the Floor (OTF)
This position supports the Process Teams by tracking/reporting/and defining continuous improvement goals, on-the-floor batch record review/determining root cause for deviations/investigation report writing, coaching/training personnel on GMP/GDP, auditing production processes for compliance to global and local procedures, and closely working with and reporting to the Process Team Lead and Quality Lead.
Your Responsibilities:
Review and approve new and revised product batch records and technical documentation associated with validation, deviations or change control activities (media fills, etc.).
Track/report/and define continuous improvement goals, determine root cause for deviation/CAPA reports, and subsequent communication back to the Process Team.
Audit production processes for compliance with global and local procedures and either create new or revise existing procedures as changes occur.
Participate and serve as an SME in internal and 3rd party audits and inspections.
Develops training plans and trains/qualifies others, including training outside of area of responsibility.
Demonstrates understanding of regulations for various countries and provides input or approval accordingly.
What You Need to Succeed (Minimum Requirements):
BS degree in relevant scientific discipline and a minimum 2 years of relevant experience in quality assurance or biological production OR High School Diploma/GED with a minimum 5 years of relevant experience in quality assurance or biological production.
Previous experience utilizing computer programs such as Microsoft suite, SAP, Veeva, Learning One Source and other relevant electronic applications.
What Will Give You a Competitive Edge (Preferences):
Previous experience with USDA/FDA regulatory requirements in a biological production environment.
Ability to make decisions with minimal supervision regarding the acceptability of product based on documentation provided.
Excellent attention to detail.
Continuously demonstrates a high level of professionalism through interactions with internal and external customers.
Must be capable of formulating new ideas for improving site performance and efficiency and working cohesively with all levels to implement ideas.
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 for eligible positions
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
Flexible work arrangements
Up to 6% 401K matching
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
