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. The EEOC "Know Your Rights" Poster is available
here.
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/ .
-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
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.