Production Event Investigator

About the role

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. The Candidate 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. Oral Solid Dosage (OSD) experience strongly preferred. 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. Why You Should Work At Catalent Spearhead exciting and innovative projects Fast-paced, dynamic environment High visibility to members at all levels of the organization 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. 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. Visit Catalent Careers to explore career opportunities. 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 DisabilityAccommodations@catalent.com . 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. Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you. Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our Ca