Senior Quality Systems Specialist
INCOG BioPharma ServicesFishers, Indiana, United States
Posted April 21, 2026
Full Time
About the Company
INCOG BioPharma is a world-class CDMO for parenteral injectable drugs.
Job Description
The Senior Quality Systems Specialist will be responsible for developing and supporting the INCOG approach to investigation processes, deviation trending and tracking, Change Control and CAPA review and evaluation board(s), and generating Quality Management System metrics, dashboards, and reporting. The Specialist will work closely with the Quality Systems Team and cross-functional departments to engage the site in performing Deviation Triage, change plan development, change actions and CAPA creation.
Requirements
- Develop and support the INCOG approach to investigation processes
- Develop and support the INCOG approach to deviation trending and tracking
- Develop and support Change Control and CAPA review and evaluation board(s)
- Generate Quality Management System metrics, dashboards, and reporting
- Work closely with the Quality Systems Team and cross-functional departments
- Engage the site in performing Deviation Triage, change plan development, change actions and CAPA creation
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance