• Document Control Specialist

    Insight Global (Durham, NC)


    Job Description

    The Document Control Specialist is responsible for printing and reviewing batch records and working with the Quality team to ensure accuracy. This role ensures that all processes are carried out in compliance with Good Manufacturing Practices (GMP) and safety regulations.

    Key Responsibilities:

    -Print and review paper batch records for compliance with Good Documentation Practices (GDP)

     

    -Reconcile batch records and collaborate with Quality Assurance on necessary comments and changes

     

    -Ensure accuracy and completeness of documentation in accordance with GMP standards

     

    -Enter data into GLIMS (Laboratory Information Management System) as needed

     

    -Maintain organized and detailed records to support manufacturing and quality operations

     

    -Adapt to daily changes and shifting priorities in a fast-paced environment

     

    We are a company committed to creating inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity employer that believes everyone matters. Qualified candidates will receive consideration for employment opportunities without regard to race, religion, sex, age, marital status, national origin, sexual orientation, citizenship status, disability, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to Human Resources Request Form (https://airtable.com/app21VjYyxLDIX0ez/shrOg4IQS1J6dRiMo) . The EEOC "Know Your Rights" Poster is available here (https://www.eeoc.gov/sites/default/files/2023-06/22-088\_EEOC\_KnowYourRights6.12ScreenRdr.pdf) .

     

    To learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/ .

     

    Skills and Requirements

     

    -Minimum 1 year of experience in a GMP-regulated environment

     

    -Strong understanding of GDP and document control processes

     

    -Experience with GLIMS or similar data entry systems preferred

     

    -Highly detail-oriented and organized

     

    -Self-motivated with the ability to work independently

    -Comfortable with change and agile in day-to-day responsibilities null

    We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion,sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military oruniformed service member status, or any other status or characteristic protected by applicable laws, regulations, andordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [email protected].