Pharma QA Documentation Coordinator

Cambrex Corp.; Charles City (IA); On-site; USD 40,000 - 50,000; Full time

Job summary

Cambrex Corp. is seeking an administrative professional to support pharmaceutical manufacturing operations by managing batch records, labels, training documentation, and controlled records in compliance with cGMP, FDA, DEA, and EPA requirements.

The role collaborates with Production and other departments to coordinate documentation, tracks training, and provides backup support for administrative tasks. Strong organization and attention to detail are essential in our regulated manufacturing

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 operational 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 Corp. is seeking an administrative professional to support pharmaceutical manufacturing operations by managing batch records, labels, training documentation, and controlled records in compliance with cGMP, FDA, DEA, and EPA requirements.

The role collaborates with Production and other departments to coordinate documentation, tracks training, and provides backup support for administrative tasks. Strong organization and attention to detail are essential in our regulated manufacturing