Production Event Investigator

Catalent; Greenville (NC); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Paid time off

Medical, dental, and vision benefits

Tuition reimbursement

Site-based engagement activities

Job summary

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus offering end-to-end solutions from formulation development through commercial manufacturing and packaging.

The Production Event Investigator will author and oversee deviations, investigations, and CAPAs within GMP timelines, collaborating with cross-functional teams to ensure root causes are identified and corrective actions implemented.

Qualifications

• Bachelor's degree with at least three years of pharmaceutical production experience.
• High School diploma with at least five years of pharmaceutical production experience.
• Experience with oral solid dosage forms preferred.
• Experience with FDA cGMP and GDP.
• Experience working within cGMP quality systems.
• Strong technical writing skills.

Responsibilities

• Own and manage quality events in Commercial Ops and packaging.
• Lead cross-functional investigations to identify root causes.
• Author deviation investigations and CAPAs within timelines.
• Document and track CAPAs for timely effectiveness.
• Provide GMP-related investigation updates to management.
• Ensure CAPA effectiveness checks are completed.
• Populate non-conformances with accurate root causes.

Skills

Pharma production

CAPA investigations

GMP experience

Technical writing

Education

Bachelor's degree or higher

High School diploma with 5+ years pharma exp

Tools

GxP systems

Job description

Catalent’s Greenville, North Carolina site is a major oral solid dose development and manufacturing campus, delivering end‑to‑end, turnkey solutions from formulation development through commercial manufacturing and packaging. The site specializes in oral solid dosage forms, supported by integrated formulation expertise, comprehensive analytical services, and scalable manufacturing capabilities designed to support both commercial products and potent or targeted therapies, including orphan drugs. Backed by more than $100 million in recent investments, the Greenville operation features fit‑for‑scale infrastructure, potent handling capabilities, and a strong regulatory track record, making it a critical part of Catalent’s global network for advancing complex oral drug programs from development to market.

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. This position offers the chance to contribute to high‑quality pharmaceutical production in a dynamic and collaborative environment.

Shift: M- F 8:00am-5:00pm

Location: Greenville, NC

100% Onsite

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.

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.

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic.
• Competitive Paid Time Off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition Reimbursement – support to finish your degree or earn a new one.
• Site-based Employee Engagement activities such as Music Bingo, Puppy Supply Donation Program, Halloween Costume Contests, Pumpkin Painting, and more.
• Employee Resource Groups focusing on Diversity and Inclusion.
• Environmentally friendly, community engagement green initiatives including regular participation in Highway Clean-up.
• Defined career path and annual performance review and feedback process with potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• WellHub program promoting overall physical and mental wellness, including an onsite fitness center.
• Perkspot offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories.

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.

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 [e-mail]. 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.