Quality Assurance Associate – Change Control Coordinator
Elanco
8 hours ago
On-site
Elwood, KS
Operations
Quality Assurance Associate – Change Control Coordinator
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
- Support deviation investigations, including 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
- Participate in audits, inspection readiness, and continuous improvement initiatives
- Manage QA projects independently with minimal oversight
- Support a strong quality culture through coaching, collaboration, and technical guidance
Minimum Qualifications:
- Bachelor’s degree in a scientific discipline (preferred)
- 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 independently manage cross-functional quality initiatives in a GMP-regulated environment
Preferred Qualifications:
- 6+ years with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.)
- Experience reviewing/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)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Strong organizational skills; manage multiple priorities
- Collaborative experience across manufacturing and quality functions
- Coaching and mentorship capabilities
Additional Information:
- Location: Elwood, KS
- Travel: Occasional
- May occasionally require support outside normal business hours to meet operational/compliance needs
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus; flexible work arrangements; up to 6% 401K matching; 9 Employee Resource Groups
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
- Support deviation investigations, including 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
- Participate in audits, inspection readiness, and continuous improvement initiatives
- Manage QA projects independently with minimal oversight
- Support a strong quality culture through coaching, collaboration, and technical guidance
Minimum Qualifications:
- Bachelor’s degree in a scientific discipline (preferred)
- 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 independently manage cross-functional quality initiatives in a GMP-regulated environment
Preferred Qualifications:
- 6+ years with change control systems and RCA tools (5 Whys, Ishikawa/6M, etc.)
- Experience reviewing/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)
- Proficiency in Microsoft Office (Word, Excel, PowerPoint)
- Strong organizational skills; manage multiple priorities
- Collaborative experience across manufacturing and quality functions
- Coaching and mentorship capabilities
Additional Information:
- Location: Elwood, KS
- Travel: Occasional
- May occasionally require support outside normal business hours to meet operational/compliance needs
Benefits:
- Multiple relocation packages; 8-week parental leave; annual bonus; flexible work arrangements; up to 6% 401K matching; 9 Employee Resource Groups