GMP Documentation & Manufacturing Support Specialist

BeOne Medicines USA; Hopewell (VA); On-site; USD 70,000 - 110,000; Full time

Job summary

BeOne Medicines USA seeks a Manufacturing Support and Documentation Control Specialist to maintain GMP records for Drug Substance and Drug Product, issuing, reconciling, and archiving master batch records, SOPs, work instructions, and labels. The role collaborates with Manufacturing, Quality, Supply Chain, Warehouse, Engineering, and Validation to ensure timely documentation for production.

Candidates should have at least four years in biopharmaceutical manufacturing, strong GMP document-control

Qualifications

• 4+ years of biopharmaceutical manufacturing experience.
• GMP documentation and document-control experience.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities and time-sensitive activities.
• Strong written and verbal communication.
• Experience working cross-functionally with Manufacturing, Quality, Supply Chain and Warehouse.
• Proficiency with Microsoft Office; familiarity with SAP and QMS systems.

Responsibilities

• Issuance of batch-related documentation and labels for GMP manufacturing.
• Reconcile GMP documentation per lifecycle requirements.
• Create and issue GMP logbooks/notebooks.
• Store and archive GMP documents and batch records.
• Perform tasks in line with safety, quality systems and cGMP requirements.
• Drive continuous improvement and support document management operations.
• Oversee revision of batch records and control documents.
• Coordinate documentation tasks across DS, DP, QA, and Warehouse.

Skills

Biopharmaceutical manufacturing

GMP documentation

Document-control practices

Organizational skills

Time management

Cross-functional collaboration

Written and verbal communication

Education

Bachelor's Degree: Science / Engineering or equivalent

Tools

SAP

QMS systems

Microsoft Office

Job description

BeOne Medicines USA seeks a Manufacturing Support and Documentation Control Specialist to maintain GMP records for Drug Substance and Drug Product, issuing, reconciling, and archiving master batch records, SOPs, work instructions, and labels. The role collaborates with Manufacturing, Quality, Supply Chain, Warehouse, Engineering, and Validation to ensure timely documentation for production.

Candidates should have at least four years in biopharmaceutical manufacturing, strong GMP document-control