Documentation Specialist

Catalent • Greenville, NC

3d • Onsite

About The Position

Documentation Specialist Position Summary 100% on-site Catalent is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. 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. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. 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 Documentation Specialist provides administrative support for commercial batch record review, EDMS, training modules and the electronic Quality Management System (eQMS).

Requirements

• High School diploma or equivalent with at least 4 years of relevant experience required
• Proficient with Microsoft Office Word, Excel, and/or Adobe Professional

Nice To Haves

• Previous documentation control/management preferred

Responsibilities

• Perform review of executed commercial batch records to ensure quality and accuracy
• Partner with commercial supervisors and operators to handle corrections and/or discrepancies within executed commercial records
• Ensure the documentation database is accurate and inputs conform to company standards
• Provide requested information during client and FDA audits (as needed)
• Ensure all errors and corrections are resolved according to SOP requirements
• Enter data into applicable spreadsheets/database
• Participate and contribute to the continued implementation of electronic document software systems

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED
• Number of Employees: 5,001-10,000 employees