Manufacturing Support and Documentation Control Coordinator
BeiGene
Summary
The Manufacturing Support Coordinator is a non-exempt position responsible for supporting document management and manufacturing support activities for Drug Substance and Drug Product manufacturing teams.
Job description
Responsibilities
- Develop and maintain the document management process for Drug Substance and Drug Product manufacturing teams
- Ensure compliance within the document management system, document issuance, reconciliation, retention, and final storage
- Ensure organizational documents are prepared, maintained, distributed, updated, and stored per document management standards
- Coordinate materials with supply chain and maintain training records for the teams
- Author deviations and change controls
- Issue batch related documentation and labels in support of GMP manufacturing
- Reconcile GMP documentation following document lifecycle requirements
- Create and issue GMP logbooks/notebooks
- Store and archive GMP documents and batch related records
- Perform tasks consistent with safety policies, quality systems and cGMP requirements
- Drive continuous improvement
- Oversee revision of Batch record, protocol and other control documents
- Scan and file documents
- Process controlled documentation within applicable system
- Format and control records and perform data entry work
- Advise and respond to queries on document status by interfacing with operation management
- Administer and manage Facilities Engineering records within HPW facility
- Assist departments with equipment and system documentation
- Coordinate system implementation and prepare documentation as necessary
- Identify process improvements and provide recommendations concerning established workflows
- Work directly with Document Management, Drug Substance, Drug Product, Warehouse, and various Quality organizations
- Manage all Turn-Over-Packages (TOP) and Commissioning Packages from HPW site projects
- Maintain close collaboration with QA, QC, DP, DS and WH operations
- Stage materials and support reservations within SAP system for Drug Substance and Drug Product
- Manage workflows and metrics for manufacturing areas
- Attend both DS and DP morning huddles
- Work with Supply Chain to coordinate the manufacturing schedule to support batch records, labels and forms requirements prior to production start
Production Support
- Drug Substance Area: Master Batch Records, Logbooks, Forms, Labels stored in designated area at least 2 days prior to production run; material staging and room readiness
- Drug Product: Master Batch Records, Logbooks, Forms, Labels stored in designated area at least 2 days prior to production run
- Warehouse: Weigh and dispense documentation and SAP reservation, materials readiness prior to campaign start
- Document Management: Workflow and process alignment for all documentation issuance including labels, Master batch records, SOPs, Work instructions, Forms
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 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
Requirements
- Minimum of 4 years biopharmaceutical manufacturing experience
- Bachelor's Degree in Science / Engineering or equivalent experience in biopharmaceutical industry
- 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
Benefits
- Medical, Dental & Vision
- 401(k)
- FSA/HSA
- Life Insurance
- Paid Time Off
- Wellness
- Annual Bonus Plan
- Equity Awards
- Employee Stock Purchase Plan
Company overview
BeiGene, Ltd., now rebranding as BeOne Medicines, is a global commercial-stage biotechnology company specializing in the discovery, development, manufacturing, and commercialization of innovative oncology medicines. Founded in 2010 by John V. Oyler and Xiaodong Wang, the company has grown into a multinational organization with headquarters in Cambridge, Massachusetts, Beijing, China, and Basel, Switzerland. BeiGene focuses on developing targeted and immune-oncology therapies for cancer treatment, with a diverse pipeline that includes internally discovered products like BRUKINSA (zanubrutinib), a Bruton's tyrosine kinase inhibitor, and Tevimbra (tislelizumab), a PD-1 inhibitor. The company operates across six continents with over 45 countries participating in clinical trials and has enrolled more than 30,000 patients in its research programs. With approximately 12,000 employees worldwide, BeiGene has established itself as a significant player in global oncology, particularly with strong market presence in China and expanding operations in the United States and Europe. The company's mission centers on expanding access to high-quality cancer therapies worldwide through persistent innovation and challenging traditional approaches to drug development.