QA Data Coordinator

Cambrex•Charles City, IA

1d•Onsite

About The Position

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.

Requirements

Strong computer skills
3 or more years of office experience

Nice To Haves

Manufacturing office background preferred
Associates Degree in Adminstration/ Business or related degree prefered

Responsibilities

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