Document Control Specialist I

Rentschler Biopharma • Milford, MA

2d • Onsite

About The Position

Our Documentation Control Specialist within our Quality groups reviews as well as verifies document records to ensure the documentation complies with regulations and internal quality assurance practices. The Document Control Specialist will manage the document and record life cycle to ensure compliance with regulatory requirements and company procedures.

Requirements

• 1+ year(s) experience in Document Control or Quality Assurance with a cGMP biotech/pharmaceutical company or other similarly regulated industry.
• Experience with document and record indexing.
• Strong demonstrated knowledge of FDA and cGMP requirements
• Experience with electronic quality management systems such as MasterControl
• Strong attention to detail and great organizational skills
• Must be a strong team player with good problem solving
• Excellent verbal and written communication skills and proficiency in Microsoft software applications

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

Benefits

• medical insurance
• 401K program
• annual discretionary bonus program

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: No Education Listed