GMP Documentation & Manufacturing Support Specialist

BeOne Medicines; Hopewell (VA); On-site; USD 44,000 - 63,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Paid Time Off

Job summary

BeOne Medicines Ltd. is seeking a Specialist for Manufacturing Support and Documentation Control in Hopewell, VA.

The role provides day-to-day GMP documentation support for Drug Substance and Drug Product manufacturing, including issuing, reconciling, maintaining, and archiving master batch records, SOPs, work instructions, forms, labels, logbooks, and validation protocols. The ideal candidate has a minimum of 4 years biopharmaceutical manufacturing experience, strong GMP documentation

Qualifications

• Bachelor’s Degree in Science/Engineering or equivalent experience in biopharmaceutical industry.
• Issuance of batch related documentation and labels in GMP manufacturing.
• Reconcile GMP documentation following document lifecycle requirements.
• Creation and issuance of GMP logbooks/notebooks.
• Storage and archival of GMP documents and batch related records.
• Coordinate system implementation and prepare documentation as necessary.

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.
• Format controlled records and perform accurate data entry.
• Assist departments with equipment and system documentation.
• Maintain collaboration with QA, QC, DP, DS and WH operations.

Skills

GMP documentation

Document control

Organizational skills

Time management

Communication skills

Cross-functional

MS Office

SAP

QMS systems

Education

Bachelor’s Degree: Science / Engineering

Tools

SAP

QMS systems

Job description

BeOne Medicines Ltd. is seeking a Specialist for Manufacturing Support and Documentation Control in Hopewell, VA.

The role provides day-to-day GMP documentation support for Drug Substance and Drug Product manufacturing, including issuing, reconciling, maintaining, and archiving master batch records, SOPs, work instructions, forms, labels, logbooks, and validation protocols. The ideal candidate has a minimum of 4 years biopharmaceutical manufacturing experience, strong GMP documentation