• Documentation Specialist

    Catalent Pharma Solutions (Greenville, NC)


    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).

    The Role

    + 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

    The Candidate

    + High School diploma or equivalent with at least 4 years of relevant experience required

    + Previous documentation control/management preferred

    + Proficient with Microsoft Office Word, Excel, and/or Adobe Professional

    + Experience with database management software

    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 (https://careers.catalent.com/us/en) 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 [email protected] . 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 [email protected] for us to investigate with local authorities.

     

    California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .