Document Control Specialist I: Quality & Regulatory Records

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

Benefits offered by this job

Medical insurance

401K program

Job summary

Rentschler Biopharma has a site in Milford, MA and seeks a Documentation Control Specialist to manage quality documents and records within our QA group. You will ensure regulatory compliance for document life cycles and support audits and inspections.

The role requires attention to detail, teamwork, and experience with electronic QMS tools such as MasterControl. Familiarity with FDA/cGMP is essential, and MS Office proficiency is expected.

Qualifications

• 1+ year experience in Document Control or Quality Assurance in a regulated biotech/pharma setting.
• Experience with document and record indexing.
• Strong knowledge of FDA and cGMP requirements.
• Experience with electronic quality management systems such as MasterControl.
• Excellent verbal and written communication skills and proficiency in Microsoft Office applications.

Responsibilities

• Support and manage documents in the electronic Quality Management System in compliance with regulatory requirements.
• Issue and reconcile logbooks, batch records and controlled forms.
• Maintain inventory, storage, and transfer to offsite archive.
• Scan original records and ensure they are true copies.
• Support retrieval of records for audits, inspections, and related activity.
• Format clear, detailed, and well-designed documents.
• Support QA inspections and customer audits.

Skills

Attention to detail

Team player

Excellent communication

Tools

MasterControl

Job description

Rentschler Biopharma has a site in Milford, MA and seeks a Documentation Control Specialist to manage quality documents and records within our QA group. You will ensure regulatory compliance for document life cycles and support audits and inspections.

The role requires attention to detail, teamwork, and experience with electronic QMS tools such as MasterControl. Familiarity with FDA/cGMP is essential, and MS Office proficiency is expected.