Production Event Investigator

Catalent • Greenville, NC

3d • Onsite

About The Position

Catalent is hiring a Production Event Investigator at its Greenville, North Carolina site, a pharmaceutical development and manufacturing campus specializing in oral solid dosage forms. The role supports Commercial Operations by authoring and overseeing deviations, investigations, corrective and preventive actions (CAPAs), and related reports within established timelines. The investigator collaborates with cross-functional teams to identify root causes, implement CAPAs promptly, and maintain Good Manufacturing Practice (GMP) compliance.

The position covers quality events related to Commercial Operations, Packaging, Pharmaceutical Development, and minor laboratory investigations associated with manufacturing. The schedule is Monday through Friday, 8:00 a.m. to 5:00 p.m., and the position is 100% onsite in Greenville, North Carolina.

Requirements

• Bachelor's degree and at least three years of relevant pharmaceutical experience in production or a related on-the-floor support function; alternatively, a high school diploma and at least five years of such experience.
• Experience with FDA cGMP and Good Documentation Practices (GDP).
• Experience working within cGMP quality systems.
• Strong technical writing skills.

Nice To Haves

• Experience with oral solid dosage forms.

Responsibilities

• 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 CAPAs to ensure timely implementation and effectiveness.
• Provide timely updates to management on the status of GMP-related investigations.
• Monitor and ensure CAPA effectiveness checks are completed.
• Populate non-conformances and ensure records are factual, accurate, and properly investigated to determine probable root cause.

Benefits

• Competitive paid time off and 8 paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Site-based employee engagement activities.
• Employee Resource Groups focused on diversity and inclusion.
• Defined career path and annual performance review and feedback process, with potential for career growth.
• WellHub wellness program, including an onsite fitness center.
• Perkspot discounts from approximately 900 or more merchants.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level