Entry-Level Document Control Specialist – QA & Compliance

Rentschler Biopharma, Inc.; Milford, Northern (MA, KY); Hybrid; USD 70,000 - 80,000; Full time

Job summary

Rentschler Biopharma, Inc. is seeking a Document Control Specialist I in Milford, MA to manage and verify documentation within the Quality Management System, ensuring regulatory compliance and accurate records.

The role supports audits and inspections, maintains logbooks and batch records, and formats clear documents while adhering to cGMP standards. Strong organizational skills and attention to detail are essential.

Qualifications

• 1+ year experience in Document Control or Quality Assurance in a cGMP biotech/pharma setting.
• Experience with document and record indexing.
• Knowledge of FDA and cGMP requirements.
• Experience with electronic quality management systems such as MasterControl.

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.
• Ensure compliance with all regulatory standards, systems, procedures, and practices, including cGMPs and other regulatory requirements.
• Other duties as required

Skills

Attention to detail

Organizational skills

Team player

Problem solving

Verbal communication

Written communication

Microsoft Office

Tools

MasterControl

Job description

Rentschler Biopharma, Inc. is seeking a Document Control Specialist I in Milford, MA to manage and verify documentation within the Quality Management System, ensuring regulatory compliance and accurate records.

The role supports audits and inspections, maintains logbooks and batch records, and formats clear documents while adhering to cGMP standards. Strong organizational skills and attention to detail are essential.