QA Data Coordinator in Charles City, Iowa at Cambrex

This position provides critical administrative and documentation support for pharmaceutical manufacturing operations by managing batch records, labels, training documentation, and controlled records in compliance with cGMP, FDA, DEA, and EPA requirements. The role ensures production documentation is accurate, organized, and available to support daily manufacturing activities while maintaining filing systems, logbooks, and compliance records. Working closely with Production and other departments, this individual coordinates documentation, tracks training and supplements, and provides backup support for operational administrative functions. Success in this role requires strong organizational skills, attention to detail, computer proficiency, and the ability to thrive in a regulated manufacturing environment.

• Issue requested batch records for next day’s production and attach necessary stamped labels
• Label coordination/management-design, etc.
• Order labels for Production, check in labels, maintenance of label storage according to cGMP regulations.
• Issue and track training records for all records, including batch records, SOPs and other miscellaneous required training
• Maintain MSDS Sheets
• WFI auditing and document maintenance
• Filing of SOPs, Product specs, RM specs and other miscellaneous filing as needed
• Log book updates and auditing
• Maintain work center logs and equipment logs in an orderly manner
• Track supplements and ensure proper closure and follow up
• Back up Admin Assistant as needed on batch record entry and other miscellaneous operations assignments
• File completed batch records and other filing as necessary. Maintain tight control of batch record files

• Strong computer skills
• Manufacturing office background preferred

• 3 or more years of office experience
• Associates Degree in Adminstration/ Business or related degree prefered