Biopharma Documentation & Manufacturing Support Coordinator

BeOne Medicines USA; Hopewell (VA); On-site; USD 70,000 - 90,000; Full time

Job summary

BeOne Medicines USA is hiring a Manufacturing Support Coordinator to support the document management process for Drug Substance and Drug Product manufacturing teams in a GMP environment. This non-exempt role requires attention to detail and adherence to regulatory standards.

You will issue and reconcile GMP documents, maintain logbooks, store records securely, coordinate with supply chain and QA/QC, and help drive continuous improvement.

Qualifications

• 4+ years biopharmaceutical manufacturing experience.
• Bachelor's Degree: Science / Engineering or equivalent experience in biopharmaceutical industry.
• Experience developing and maintaining the document management process for Drug Substance and Drug Product manufacturing teams.
• Must ensure compliance within the document management system, document issuance, reconciliation, retention, and final storage.
• Ability to prepare, maintain, distribute, update, and store organizational documents according to standards.

Responsibilities

• Issuance of batch related documentation and labels in support of GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Creation and issuance of GMP logbooks/notebooks.
• Responsible for storage and archival of GMP documents and batch related records.
• Perform tasks in a manner consistent with safety policies, quality systems and cGMP requirements.
• Drive continuous improvement.
• Support Document Management Operations team.
• Oversee revision of Batch record, protocol and other control documents.
• Scan and file documents.
• Processing controlled documentation within applicable system.
• Format and data entry work.
• Advise and respond to queries on document status by interfacing with operation management.
• Collaborate with QA, QC, DP, DS and WH operations.

Skills

Attention to detail

Time management

Team player

Communication

Problem solving

Education

Bachelor's Degree in Science/Engineering

Tools

SAP

Excel

Outlook

Word

Job description

BeOne Medicines USA is hiring a Manufacturing Support Coordinator to support the document management process for Drug Substance and Drug Product manufacturing teams in a GMP environment. This non-exempt role requires attention to detail and adherence to regulatory standards.

You will issue and reconcile GMP documents, maintain logbooks, store records securely, coordinate with supply chain and QA/QC, and help drive continuous improvement.