Document Control Specialist I — cGMP QA

Rentschler Biopharma SE; Milford (MA); On-site; USD 70,000 - 80,000; Full time

Benefits offered by this job

Medical insurance

401K program

Job summary

Rentschler Biopharma SE in Milford, MA is seeking a Documentation Control Specialist to manage and verify records in our Quality group, ensuring compliance with regulatory requirements and cGMP standards.

You will issue, reconcile, and archive logbooks and batch records, support inspections and audits, and help maintain a robust electronic quality management system using MasterControl. Strong attention to detail and teamwork are essential.

Qualifications

• Experience in Document Control or Quality Assurance in a regulated biotech/pharma setting.
• Strong knowledge of FDA and cGMP requirements.
• Excellent attention to detail and organizational skills.

Responsibilities

• Support and manage documents and records in the electronic Quality Management System in compliance with regulatory requirements.
• Issue and reconcile logbooks, batch records and controlled forms.
• Maintain a record of inventory, storage, and transfer to offsite archive.
• Scan original records and ensure they are a true copy of the original documents.
• Support retrieval of records for audits, inspections, and related activity as needed.
• Format clear, detailed, and well-designed documents.
• Support Regulatory Inspections and Customer Audits.
• Support QA Document Control projects and initiatives as required.

Skills

Document control

Quality assurance

FDA compliance

cGMP knowledge

MS Office

Tools

MasterControl

Job description

Rentschler Biopharma SE in Milford, MA is seeking a Documentation Control Specialist to manage and verify records in our Quality group, ensuring compliance with regulatory requirements and cGMP standards.

You will issue, reconcile, and archive logbooks and batch records, support inspections and audits, and help maintain a robust electronic quality management system using MasterControl. Strong attention to detail and teamwork are essential.