REGISTRIEREN

Dieses Stellenangebot ist nicht mehr verfügbar

XX

Quality Assurance Associate - Investigation Coordinator

Elanco
  • US
    Wathena, Kansas, United States
  • US
    Wathena, Kansas, United States

Über

Quality Assurance Associate – Investigation Coordinator As the Quality Assurance Associate – Investigation Coordinator, you’ll partner cross‑functionally with Manufacturing, Warehouse, Facilities, Quality Control, and Quality Assurance teams to support and oversee the site deviation and investigation management processes. You’ll help drive investigations, root cause analysis, and corrective actions to timely closure while ensuring compliance with GMP and regulatory expectations. This role serves as a key partner in maintaining site quality standards, supporting continuous improvement initiatives, and strengthening operational compliance across the facility.
Responsibilities
Coordinate and oversee daily activities within the site deviation management system
Lead and support deviation investigations to timely and compliant closure
Facilitate or support Deviation Review Board (DRB) activities and cross‑functional collaboration
Drive and coach root cause analysis (RCA) activities using tools such as 5 Whys and Ishikawa/6M
Ensure appropriate CAPAs are identified and implemented to reduce recurrence of deviations
Communicate investigation status updates and timelines across departments
Lead or assist customer complaint investigations as needed
Support site change controls, including impact assessments and quality reviews
Provide technical review and guidance for investigations, documentation, and quality records
Write, revise, and maintain QA procedures and controlled documents
Support site quality metrics related to deviations, investigations, and complaint management
Identify trends and support continuous improvement initiatives
Promote a strong safety and quality culture through collaboration, mentorship, and technical coaching
Minimum Qualifications
Education: Bachelor’s degree in a scientific discipline preferred
Experience: 6 years of Quality Assurance experience within a regulated industry (FDA, USDA, ISO, etc.)
Top 2 Skills: Strong investigation and root cause analysis expertise combined with the ability to independently manage cross‑functional quality initiatives in a GMP‑regulated manufacturing environment.
Preferred Qualifications
5+ years of experience with investigations, deviation management, and RCA tools (5 Whys, Ishikawa/6M, etc.)
Experience reviewing and approving GMP documentation, investigations, and CAPAs
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
Experience within animal health or pharmaceutical manufacturing environments
Location Elwood, KS
Travel Occasional
Benefits
Multiple relocation packages
8‑week parental leave
9 Employee Resource Groups
Annual bonus offering
Flexible work arrangements
Up to 6% 401(k) 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.
Elanco may use automated tools, including AI, to support parts of our recruitment process, such as reviewing applications against job‑related criteria and/or transferable 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.
#J-18808-Ljbffr
  • Wathena, Kansas, United States

Sprachkenntnisse

  • English
Hinweis für Nutzer

Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.