Biopharma Documentation & Manufacturing Support Specialist

BeiGene Ltd.; Hopewell (VA); On-site; USD 44,000 - 63,000; Full time

Benefits offered by this job

Comprehensive benefits package

Annual bonus plan (where applicable)

Equity opportunities

Job summary

BeOne Medicines Ltd. seeks a Manufacturing Support and Documentation Control Specialist to provide day-to-day document control and operational support for Drug Substance and Drug Product manufacturing.

The role handles issuance, reconciliation, maintenance, and archival of GMP docs including batch records, SOPs, and forms, interfacing with Manufacturing, Quality, Supply Chain, and Validation. Responsibilities include document lifecycle management, system-based workflows, training records,

Qualifications

• Minimum of 4 years biopharmaceutical manufacturing experience.
• Strong knowledge of GMP documentation and document-control practices.
• Excellent organizational skills and attention to detail.
• Ability to manage multiple priorities and time-sensitive manufacturing activities.
• Strong written and verbal communication skills.
• Experience working cross-functionally with Manufacturing, Quality, Supply Chain, and Warehouse.

Responsibilities

• Issue GMP batch-related documentation and labels.
• Reconcile GMP documentation following lifecycle requirements.
• Create and issue GMP logbooks/notebooks.
• Store and archive GMP documents and batch records.
• Support document management operations and system workflows.
• Collaborate with QA, QC, DP, DS, and WH teams to ensure compliance.
• Assist in equipment and system documentation; coordinate implementations.
• Identify process improvements and provide recommendations.

Skills

Biopharma manufacturing

GMP documentation

Organizational skills

Time management

Communication skills

Cross-functional teamwork

SAP familiarity

QMS familiarity

Education

Bachelor’s Degree: Science / Engineering

Tools

SAP

QMS

Microsoft Office

Job description

BeOne Medicines Ltd. seeks a Manufacturing Support and Documentation Control Specialist to provide day-to-day document control and operational support for Drug Substance and Drug Product manufacturing.

The role handles issuance, reconciliation, maintenance, and archival of GMP docs including batch records, SOPs, and forms, interfacing with Manufacturing, Quality, Supply Chain, and Validation. Responsibilities include document lifecycle management, system-based workflows, training records,