Production Event Investigator
Catalent Pharma Solutions
Summary
We have an opportunity for a Production Event Investigator to join our team. In this role, you will be responsible for authoring and overseeing the completion of deviations, investigations, corrective and preventive actions (CAPAs), and related reports within established timelines for Commercial Operations. You will collaborate with cross-functional teams to identify root causes, ensure timely implementation of CAPAs, and maintain compliance with Good Manufacturing Practices.
Job description
Position Summary
We have an opportunity for a Production Event Investigator to join our team. In this role, you will be responsible for authoring and overseeing the completion of deviations, investigations, corrective and preventive actions (CAPAs), and related reports within established timelines for Commercial Operations. You will collaborate with cross-functional teams to identify root causes, ensure timely implementation of CAPAs, and maintain compliance with Good Manufacturing Practices.
The Role
- Own and manage quality events related to Commercial Operations, Packaging, Pharmaceutical Development, and minor laboratory investigations associated with manufacturing.
- Lead cross-functional teams, when appropriate, to investigate complex quality events.
- Author deviation investigations within required timelines.
- Partner with functional areas to identify root causes and determine appropriate corrective and preventive actions.
- Initiate, document, and track corrective and preventive actions (CAPAs) to ensure timely implementation and effectiveness.
- Provide timely updates to management on the status of Good Manufacturing Practice (GMP)-related investigations.
- Monitor and ensure CAPA effectiveness checks are completed.
- Populate non-conformances to ensure records are factual, accurate, and properly investigated to determine probable root cause.
The Candidate Minimum Requirements
- Bachelor's degree with at least three years of relevant pharmaceutical experience in production or a related on-the-floor support function.
- High School diploma with at least five years of relevant pharmaceutical experience in production or a related on-the-floor support function.
Preferred Skills & Background
- Experience with oral solid dosage forms preferred.
- Experience with Food and Drug Administration (FDA) Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).
- Experience working within cGMP quality systems.
- Strong technical writing skills.
Requirements
- Bachelor's degree with at least three years of relevant pharmaceutical experience in production or a related on-the-floor support function
- High School diploma with at least five years of relevant pharmaceutical experience in production or a related on-the-floor support function
- Experience with FDA Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP)
- Experience working within cGMP quality systems
- Strong technical writing skills
- Experience with oral solid dosage forms preferred
Benefits
- Paid Time Off
- 8 Paid Holidays
- Medical, Dental & Vision
- Tuition Reimbursement
- Employee Resource Groups
- Wellness Program
- Onsite Fitness Center
- Employee Discounts
Company overview
Catalent Pharma Solutions, now known as Catalent, Inc., is a leading global contract development and manufacturing organization (CDMO) headquartered in Tampa, Florida. Founded in 2007 as a spin-off from Cardinal Health's pharmaceutical technologies segment, the company has grown into a major player in the pharmaceutical services industry. Catalent provides comprehensive drug development and manufacturing solutions including drug delivery technologies, formulation development, analytical testing, clinical and commercial manufacturing, clinical packaging, and supply chain services. The company operates over 50 facilities across four continents and has supported more than half of all FDA-approved products over the past decade. With approximately 16,900 employees, Catalent produces over 70 billion doses annually for more than 8,000 products, serving major pharmaceutical companies like Pfizer, Moderna, Novo Nordisk, and Bristol-Myers Squibb. In 2024, the company was acquired by Novo Holdings A/S for $16.5 billion, further strengthening its position in the global pharmaceutical manufacturing landscape.