Manufacturing Support and Documentation Control 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 continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.

Experience Required:

• Minimum of 4 years biopharmaceutical manufacturing experience.

Education Required:

• Bachelor's Degree: Science / Engineering or equivalent experience in biopharmaceutical industry.

The Manufacturing Support Coordinator role is a non - exempt position responsible for supporting the following activities but not limited to:

Developing and maintaining the document management process for Drug Substance and Drug Product manufacturing teams.

Ensure compliance within the document management system, document issuance, reconciliation, retention when in use within department, and final storage.

The coordinator will ensure that the organizational documents are prepared, maintained, distributed, updated, and stored according to the organization's document management standards.

Besides document management other responsibilities may include material management such coordinating of materials with supply chain, maintenance of training records for the teams, authoring of deviations and change controls. Other responsibilities may be added as needs of the department may expand.

Required Skills/Attributes:

• Support Document Management Operations team
• Oversee revision control
• Scan and file documents
• Supporting project tasks
• Supporting the Material Specification project team
• Processing controlled documentation within the customers system
• Formatting to structure record and data entry work
• Advising and responding to queries on document status by interfacing with operation management
• Demonstrated ability to successfully gown into aseptic manufacturing areas
• Excellent organization and time-management skills required
• Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure
• Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self Confidence & Ability to Accept & apply Lessons Learned as needed
• Works with a sense of urgency, while engaging and listening to experts
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills
• Strong organizational skills with the proven ability to prioritize
• Must be dependable and punctual
• Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word
• Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs
• Customer/Client Focus

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 the 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.
• Supporting project tasks.
• Processing controlled documentation within applicable system.
• Formatting to structure and formatting control record and data entry work.
• Advising and responding to queries on document status by interfacing with operation management.
• Responsible for the administration and management of Facilities Engineering records in an effective and efficient method within HPW facility.
• Prepare and organize documentation procedures following.
• Assist departments with equipment and system documentation. Coordinate system implementation and prepare documentation as necessary.
• Identify specific process improvement as needed and provide recommendations concerning established workflows.
• Work directly with Document Management, Drug Substance, Drug Product, Warehouse, and various Quality organizations.
• Maintain open communication with management, co-workers, customers and counterpart staff in other sites.
• Manage all Turn-Over-Packages (TOP) and Commissioning Packages from HPW site projects.
• Maintain open communication with management, co-workers, customers, and counterpart stain in other sites as needed (GZ).
• Maintain close collaboration with QA, QC, DP, DS and WH operations.
• Material Staging and support with reservations within SAP system for Drug Substance and Drug Product
• Managing workflows and metrics for manufacturing areas.

Key Relationships:

• Must attend both the DS and DP, morning huddles.
• Works in a collaborative team setting with quality counterparts that include Manufacturing Operations, Engineering and Validation, Quality Control, Quality Assurance Manufacturing, Supply Chain and Warehouse.
• Manage all Turn-Over-Packages (TOP) and Commissioning