Production Event Investigator
The Production Event Investigator will support the Commercial Operations team. The production Event Investigator will lead and author GMP investigations, deviations, and CAPAs to ensure the highest levels of product quality and regulatory compliance. You will work closely with cross‑functional teams across Manufacturing, Packaging, Pharmaceutical Development, and Quality functions to drive timely, accurate, and effective resolution of quality events.
Position Summary
This position is 100% on-site at the Greenville site.
Catalent’s Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial manufacturing, and packaging. This state-of-the-art facility has had over $100M of investments in recent years and features fit-for-scale capacity with potent handling capabilities, ideal for orphan or targeted drug development.
This opportunity will focus on technical writing skills, MP expertise, and a passion for continuous improvement within a fast-paced pharmaceutical environment.
The Role
Own and manage quality events related to Commercial Operations, Packaging, Pharmaceutical Development, and minor lab investigations.
Lead cross‑functional teams to investigate complex quality events and identify true root causes.
Author deviation investigations and ensure completion within required timelines.
Partner with teams to develop appropriate corrective and preventive actions (CAPAs).
Initiate, document, track, and verify CAPA effectiveness.
Maintain accurate, compliant GMP and GDP documentation.
Provide timely status updates on investigations and CAPA progress to management.
All other duties as assigned.
The Candidate
Bachelor’s degree and at least three years of relevant pharmaceutical manufacturing or on‑the‑floor support experience OR High school diploma and at least five years of relevant pharmaceutical experience required.
Oral Solid Dosage (OSD) experience strongly preferred.
Knowledge of regulatory agency requirements and cGMP/GDP.
Experience working within GMP quality systems.
Strong technical writing and investigation skills.
Ability to work in a manufacturing environment. Ability to stand, walk, and sit for extended periods. Lift up to 25 lbs as needed.
Ability to wear PPE, including full GMP gowning.
Why You Should Work At Catalent
Spearhead exciting and innovative projects
Fast-paced, dynamic environment
High visibility to members at all levels of the organization
152 hours of PTO + 8 paid holidays
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer, including disability and veterans.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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