Hiring: Production Document Control Area Specialist I - SDF (BULK) Company: Novo Nordisk Location: Durham, NC Job Posted Time: 2026-09-16 19:41:44 About the job Experience: •100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes & obesity. Being part of Novo Nordisk allows our employees to embark on the opportunity to help improve the quality of life for millions of people around the world. Required Skills: •Support continuous improvement within area •Issue and track all batch related documentation •Conduct real-time and post-execution batch reviews, including the evaluation of batch production records (BPRs), logbooks and related documentation, to ensure timely batch release and compliance with approved procedures and regulatory requirements •Provide document support for Annual Product Review, Audit and Inspections and other requests as necessary •Execute process confirmation for procedures related to Document Control •Ensure site compliance with cGMPs, ISO standards corporate & local SOPs •Support minor deviations •Follow all safety & environmental requirements in the performance of duties Qualifications: •Demonstrated capacity to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time. (% can change on a case-by-case basis based on the role). •Associate’s Degree in Technology, Life Science, Pharma or a relevant field of study from an accredited college or university required and one (1) year of experience operating in a GMP regulated environment and two (2) years of experience of word processing & electronic document distribution •Demonstrated knowledge of requirements/expectations of regulatory authorities e.g. FDA required •Proficiency with problem solving techniques required •Demonstrated experience using strong attention to detail, proofreading & strong computer skills with a willingness to learn new IT systems required •Excellent written & oral communication skills required •Demonstrated capacity to work in a team for batch reviews required •Bachelor’s Degree Technology, Life Science, Pharma or a relevant field of study from an accredited university preferred •Proven ability to establish & maintain networks & facilitate processes that encourage cross organizational knowledge sharing preferred •We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!