Production Event Investigator

Catalent Pharma SolutionsGreenville, NC
18hOnsite

About The Position

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.

Requirements

  • 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.
  • 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.

Nice To Haves

  • Oral Solid Dosage (OSD) experience strongly preferred.

Responsibilities

  • 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.

Benefits

  • 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.
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service