Specialist III – Quality Assurance, Systems
Position Summary:
- Work Schedule: M-F 8am-5pm
- 100% on-site
We have an opportunity for a Specialist III – Quality Assurance, Systems to join our team. This role is accountable for the Investigation and CAPA Management Systems. You will manage complex and high-level deviations, support Out-of-Specification investigations, and collaborate with internal stakeholders to ensure effective execution of these systems. The position also focuses on maintaining and improving Quality Systems, reporting metrics, and implementing process enhancements to support compliance and operational excellence.
The Role:
- Perform quality review and approval on deviations, laboratory investigations, and complaints
- Oversee Corrective and Preventive Actions (CAPAs) opened in response to deviations
- Address client comments on investigations
- Participate in client calls to discuss investigation status
- Engage in customer contact as required
- Provide technical assistance and training for personnel
- File and maintain controlled documents
- All other duties as assigned.
The Candidate:
- Doctorate Degree in a STEM discipline with a minimum of 6 years of related experience
- OR Master’s Degree in a STEM discipline with a minimum of 8 years of related experience
- OR Bachelor’s Degree in a STEM discipline with a minimum of 10 years of related experience
- OR Associate’s Degree in a STEM discipline with a minimum of 14 years of related experience
Why you should join Catalent:
- Defined career path with annual performance reviews and feedback process
- Diverse and inclusive culture
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- Competitive paid time off plus 8 paid holidays
- Community engagement and green initiatives
- Medical, dental, and vision benefits effective day one of employment
- Tuition reimbursement
