Specialist, Manufacturing Support and Documentation Control

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.
• Format controlled records and perform accurate data entry in accordance with established documentation standards.
• Advising and responding to queries on document status by interfacing with operation management.
• Prepare, organize, and maintain documentation in accordance with established procedures and cGMP requirements.
• 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 close collaboration with QA, QC, DP, DS and WH operations.
• 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 staff in other sites as needed. 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: Drug Substance Area: Master Batch Records, Logbooks, Forms, Labels etc. are all stored in the designated area on the manufacturing floor at least 2 days prior to the production run. Material Staging and room readiness. Drug Product: Master Batch Records, Logbooks, Forms, Labels etc. are all stored in the designated area on the manufacturing floor at least 2 days prior to the 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 issuances 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.