Technical Investigation Writer
The Technical Investigation Writer is responsible for authoring, managing, and coordinating quality event investigations, deviations, CAPAs,
and other various documents that support Pharmaceutical Development Operations. The role works cross‑functionally to ensure high‑quality, compliant documentation, effective root cause analysis, accurate batch execution inputs, and timely completion of quality system requirements.
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.
The Technical Investigation Writer will own, manage, and investigate quality events related to Pharmaceutical Development.
The Role
Lead cross functional teams in the investigation of complex deviations and nonconformances-functional teams in the investigation of complex deviations and non-conformances.
Author deviation investigations and associated reports within required timeframes.
Work with functional areas to determine probable root cause(s) and identify appropriate corrective and preventative actions.
Maintain hardcopy and electronic files in the appropriate software or database systems.
Interface with regulated computer systems to ensure accurate document flow, work order inputs, and data integrity for on time batch execution-time batch execution.
Ensure documentation databases and MRP inputs are accurate to support manufacturing activities.
Provide required documentation or information during client and FDA audits.
All other duties as assigned.
The Candidate
Master’s degree in science-related or engineering discipline required or;
Bachelor's degree in a science-related or engineering discipline with two years of relevant experience required or;
Associate’s degree in a science-related or engineering discipline with three years of relevant experience required or;
High school diploma or equivalent with five years of relevant experience required.
Knowledge of regulatory agency requirements and cGMP quality systems preferred.
Experience with deviations, investigations, CAPA activities and technical writing preferred.
Proficiency in Microsoft Word, Excel, Adobe Professional and database management software.
individual may be required to sit, stand, walk regularly.
Occasionally lift 0-15 pounds.
Requires the use of hands for simple grasping and fine manipulation.
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.
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