QA Documentation & Records Coordinator

Cambrex; Charles City (IA); On-site; USD 40,000 - 65,000; Full time

Job summary

Cambrex is seeking an organized administrative professional to support pharmaceutical manufacturing operations by managing batch records, labels, training documentation, and controlled records in a cGMP-compliant environment.

Responsibilities include issuing batch records, coordinating labels, maintaining logs, and providing backup support for batch record entry. Strong computer skills and office experience are essential for success.

Qualifications

• 3 or more years of office experience.
• Associates Degree in Administration/Business or related degree preferred.

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

Skills

Strong computer skills

Manufacturing office background

Education

Associates Degree in Administration/Business or related degree preferred

Job description

Cambrex is seeking an organized administrative professional to support pharmaceutical manufacturing operations by managing batch records, labels, training documentation, and controlled records in a cGMP-compliant environment.

Responsibilities include issuing batch records, coordinating labels, maintaining logs, and providing backup support for batch record entry. Strong computer skills and office experience are essential for success.