Quality Assurance Associate - Change Control Coordinator

Kansas Ag Connection; Elwood (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Multiple relocation packages

8-week parental leave

Annual bonus offering

Flexible work arrangements

Up to 6% 401K matching

Job summary

Kansas Ag Connection is looking for a Quality Assurance Associate - Change Control Coordinator in Elwood, New York. This role involves coordinating the change management process and collaborating with various teams to ensure compliance with quality standards.

The ideal candidate will have a Bachelor's degree and at least 8 years of experience in Quality Assurance within a regulated industry. Knowledge of change control and root cause analysis is essential for success in this position.

Competitive benefits such as flexible work arrangements and parental leave are offered.

Qualifications

• 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.).
• Strong expertise in change control and root cause analysis.
• Ability to manage cross-functional quality initiatives in a GMP-regulated environment.

Responsibilities

• Coordinate and oversee daily activities within the site change management system.
• Lead or support Change Review Board (CRB) activities.
• Drive change controls to closure in a timely and compliant manner.
• Support deviation investigations, including root cause analysis and CAPA development.
• Write, revise, and maintain QA procedures and controlled documents.

Skills

Change control expertise

Root cause analysis

Quality documentation review

Technical writing

Collaboration skills

Education

Bachelor's degree in a scientific discipline

Tools

Microsoft Office

Electronic Quality Management Systems (eQMS)

Job description

### Job Details#### Job Title:Quality Assurance Associate - Change Control Coordinator#### Location:,, ,#### Company:#### Industry Sector:#### Industry Type:#### Career Type:#### Job Type:Full Time#### Minimum Years Experience Required:N/A#### Salary:### Get Job Alerts**Career Type:** Quality Assurance**Country:** USAI agree to receive alerts from and to the .Your alert was created successfully.x## General Alert Saved* The listings below are jobs matching the criteria you've selected for your General Alert on.Criteria selected was:* General alert saved for .* General alert notifications will be sent weekly on Monday.* Please note that you can only have one general alert active at any given time. Creating a new general alert will override an existing general alert.* Visit the to manage your alerts# Quality Assurance Associate - Change Control Coordinator| Number of Years Experience: | Minimum Education Completed: | || Education Major / Discipline Category: | Most Recent / Current Occupation: | |**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: Quality Assurance Associate - Change Control Coordinator**As the Quality Assurance Associate - Change Control Coordinator, you'll partner cross-functionally with Manufacturing, Process Teams, Warehouse, Facilities, Quality Control, and Quality Assurance to support and oversee the site change management process. You'll help drive change controls, investigations, and quality systems activities to timely closure while ensuring compliance with GMP and regulatory expectations. This role serves as a key partner in maintaining site quality standards, improving processes, and supporting operational excellence across the facility.**Your Responsibilities:*** Coordinate and oversee daily activities within the site change management system* Lead or support Change Review Board (CRB) activities and facilitate cross-functional collaboration* Drive change controls to closure in a timely and compliant manner* Communicate status updates and timelines across departments to support operational alignment* Support deviation investigations, including root cause analysis (RCA) and CAPA development* Provide technical review and guidance for quality documentation, investigations, and change controls* Write, revise, and maintain QA procedures and controlled documents* Support site quality metrics related to change management and identify trends as applicable* Participate in audits, inspection readiness activities, and continuous improvement initiatives* Manage QA projects independently with minimal oversight* Support a strong quality culture through coaching, collaboration, and technical guidance**What You Need to Succeed (minimum qualifications):**Education: Bachelor's degree in a scientific discipline preferredExperience: 8 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)Top 2 Skills: Strong expertise in change control and root cause analysis combined with the ability to independently manage cross-functional quality initiatives in a GMP-regulated environment.What Will Give You a Competitive Edge (preferred qualifications):6+ years of experience with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.)* Experience reviewing and approving GMP documentation, investigations, and change controls* Strong technical writing and communication skills* Experience with risk assessment tools and quality metrics reporting* Experience with electronic Quality Management Systems (eQMS)* Demonstrated proficiency in Microsoft Office applications (Word, Excel, PowerPoint)* Ability to manage multiple priorities with strong organizational skills* Experience working collaboratively across manufacturing and quality functions* Strong coaching and mentorship capabilities**Additional Information:*** Travel: Occasional* Location: Elwood, KS* This role primarily supports standard business operations but may occasionally require support outside of normal business hours to meet operational or compliance needs.Studies have shown underrecognized 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* 8-week parental leave* 9 Employee Resource Groups* Annual bonus offering* Flexible work arrangements* Up to 6% 401K matchingElanco 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.To apply please click on APPLY TO THIS POSITIONJob Post Date: 05/29/26Here are some other jobs you may be interested in applying for.| | || - | - || Elanco Elwood, Kansas | Elanco Elwood, Kansas || Elanco Elwood, Kansas | |2 people are interested in this job.