Production Event Investigator

Catalent Pharma Solutions • Greenville, NC

5d • Onsite

About The Position

Catalent’s Greenville, North Carolina site is an oral solid dose development and manufacturing campus providing formulation development, analytical services, manufacturing, and packaging. The Production Event Investigator joins Commercial Operations and is responsible for authoring and overseeing deviations, investigations, corrective and preventive actions (CAPAs), and related reports within established timelines. The role collaborates with cross-functional teams to identify root causes, implement CAPAs promptly, and maintain Good Manufacturing Practice compliance. The position is 100% onsite in Greenville, North Carolina, with a Monday–Friday, 8:00 a.m.–5:00 p.m. schedule.

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 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.

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

Benefits

• Competitive paid time off and eight paid holidays.
• Medical, dental, and vision benefits effective on the first day of employment.
• Tuition reimbursement.
• Employee Resource Groups focused on diversity and inclusion.
• WellHub wellness program, including an onsite fitness center.
• Perkspot discounts from approximately 900 or more merchants.
• Career growth opportunities, a defined career path, and an annual performance review and feedback process.

What This Job Offers

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