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.
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.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
