GMP Quality Investigations Lead — Deviation & CAPA

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 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.