Elanco Animal Health Incorporated
Assistant - QA Document Control
Elanco Animal Health Incorporated, Fort Dodge, Iowa, United States, 50501
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: Assistant - QA Document Control
The purpose of this position is to support the site's overall document control system. The Quality Control Assistant issues manufacturing batch records and packaging procedures according to schedule, oversees controlled documents in the site document management system, maintains document control filing system, ensures compliance with site requirements for documentation, archival and retention, and assists during inspections.
Your Responsibilities:Prepares, reviews, and issues batch records, ensuring compliance to Good Documentation Practices, regulations (cGMP, 9 CFR) and company SOPs.Manages document control systems, trains staff on good documentation practices and maintains document traceability and retrieval.Implements batch record holds per deviation impact assessments, initiates deviations in quality systems for non-conformances and ensures timely QA approvals, and maintains document control area in an inspection-ready state.Participates in CAPA teams, investigates deviations, and ensures timely and accurate completion of CAPAs to address non-conformances.Actively participates in and leads projects, contributing to idea generation, solution development, and process improvement. Ensures timely project completion and demonstrates strong teamwork and collaboration skills.Participates in internal audits, prepares for regulatory agency audits and customer inspections, and provides support during inspections, including demonstrating job tasks as needed.What You Need to Succeed (Minimum Qualifications):
High School Diploma/GEDStrong attention to detail with a quality assurance mindset.Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents.Ability to perform basic mathematical calculations are required.What Will Give You the Competitive Edge (Preferred Qualifications):
Additional education (Bachelors or Associates degree)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:
Two 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
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
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: Assistant - QA Document Control
The purpose of this position is to support the site's overall document control system. The Quality Control Assistant issues manufacturing batch records and packaging procedures according to schedule, oversees controlled documents in the site document management system, maintains document control filing system, ensures compliance with site requirements for documentation, archival and retention, and assists during inspections.
Your Responsibilities:Prepares, reviews, and issues batch records, ensuring compliance to Good Documentation Practices, regulations (cGMP, 9 CFR) and company SOPs.Manages document control systems, trains staff on good documentation practices and maintains document traceability and retrieval.Implements batch record holds per deviation impact assessments, initiates deviations in quality systems for non-conformances and ensures timely QA approvals, and maintains document control area in an inspection-ready state.Participates in CAPA teams, investigates deviations, and ensures timely and accurate completion of CAPAs to address non-conformances.Actively participates in and leads projects, contributing to idea generation, solution development, and process improvement. Ensures timely project completion and demonstrates strong teamwork and collaboration skills.Participates in internal audits, prepares for regulatory agency audits and customer inspections, and provides support during inspections, including demonstrating job tasks as needed.What You Need to Succeed (Minimum Qualifications):
High School Diploma/GEDStrong attention to detail with a quality assurance mindset.Good written communication skills, including attention to detail, ability to follow written procedures, SOPs, specifications and other documents.Ability to perform basic mathematical calculations are required.What Will Give You the Competitive Edge (Preferred Qualifications):
Additional education (Bachelors or Associates degree)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:
Two 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
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