Manufacturing Support and Documentation Control Coordinator

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.

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.

Experience Required:

Minimum of 4 years biopharmaceutical manufacturing experience.

Education Required:

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

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 Packages from HPW site projects.

Maintain open communication with management, co-workers, customers, and counterpart stain in other sites as needed (GZ).

Work with Supply Chain to coordinate the manufacturing schedule to support the batch records, labels and forms requirements prior to the start of production.

Production Support:

The position will be trained and may also support the following on the manufacturing floor areas as needed basis:

1.Drug Substance Area:

Master Batch Records, Logbooks, Forms, Labels etc are all stored in the designated are on the manufacturing floor at least 2 days prior to the production run. Material Staging and room readiness.

2.Drug Product:

Master Batch Records, Logbooks, Forms, Labels etc. are all stored in the designated are on the manufacturing floor at least 2 days prior to the production run.

3.Warehouse:

Weigh and dispense Documentation and SAP reservation, Materials readiness prior to campaign start.

4. Document Management:

Workflow and process alignment for all documentation issuance including labels, Master batch records, SOPs, Work instructions, Forms, etc.

Physical Requirements:

Must be able to stand for long periods, up to 8 to 12 hours/day.

Must be able to reach above shoulder level, bend/stoop, push/pull, and handle/grip frequently.

Must be able to work scheduled 40 hours with the ability to work overtime as needed.

Must be comfortable in working in varying temperatures.

Frequent lifting, pushing, pulling, and carrying. Ability to lift to 40 lbs.

Regular reaching, bending, stooping, and twisting.

Repetitive motion and substantial movement of the wrists, hands, and/or fingers.

Environment requires dedicated gowns, depending on area.

Work with hazardous materials and chemicals.

Availability to work off shift hours and weekends on occasion.

Global Competencies

When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

• •Fosters Teamwork
• •Provides and Solicits Honest and Actionable Feedback
• •Self-Awareness
• •Acts Inclusively
• •Demonstrates Initiative
• •Entrepreneurial Mindset
• •Continuous Learning
• •Embraces Change
• •Results-Oriented
• •Analytical Thinking/Data Analysis
• •Financial Excellence
• •Communicates with Clarity

Salary Range: $29.13 - $41.13 per hour BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recru