Senior QA Specialist, 2nd shift
INCOG BioPharma ServicesFishers, Indiana, United States
Posted March 18, 2026
Full Time
About the Company
INCOG BioPharma Services specializes in injectable drug product formulation development, analytical method development, process scale-up, and formulation & filling of vials, syringes, and cartridges. The company also offers customized packaging services including labeling, device assembly, final packaging, and integrated storage solutions at various temperature conditions. INCOG's expertise lies in providing comprehensive pharmaceutical solutions that meet the highest quality standards.
Job Description
The Senior QA Specialist will support major QA programs, champion the organization's Quality Mindset, and culture of efficiency, attention to detail, and on-time delivery. They will review and approve documentation for Quality approval, collaborate with Manufacturing/Operations team, and prioritize and coordinate time in balancing production timelines with product quality assurance.
Requirements
- Bachelor's Degree in a related Science
- Minimum of 8 years of experience working in a GMP manufacturing environment
- Minimum of 4 years experience of QA oversight for GMP manufacturing
- 3 years experience as performer or reviewer in Quality Management Systems, DMS, Deviation/CAPA, and Change Control
- Excellent written and verbal communication skills
- General computer skills evidenced by hands-on work with computerized Operations equipment and reporting and data analysis software
Benefits
- Generous Paid Time Off
- 401k Matching
- Retirement Plan
- Health Insurance
- Dental Insurance
- Vision Insurance