Lead Aseptic Technician - Vaccine

70%:

Designee for shift handover and escalation of issues. Performs production in accordance with volume fluctuation, business need, and effective procedures. Acquires SAP access and orders components.  Must be flexible to ensure staffing for changing business volume and needs. Maintains training for and completes closed system connections and sampling requirements.  Coordinates movement of bulk product with managers.  Completes testing of process related filters.  Ensures all required water samples are assigned and performed. Performs routine inventories and escalates missing equipment/materials to management.  Consults schedule on a routine basis and ensure all parts and materials are available.  Orders components as needed.  Training of all new technicians. Ensures segregation of components.  

Summary of purpose/major responsibilities 

Responsible for working inside the fill area.  Performs production in accordance with volume fluctuation, business need, and effective procedures. 

Key accountabilities 

• Completes Product-Pathway Assessment  

• Takes actions and escalates issues to Managers, Equipment Technicians. Works with managers to ensure appropriate staffing.  

• Attends shift handover and steps in as a designee for managers when necessary. Updates boards and ensure commodities are available to avoid production interruptions. Updates and utilizes the OMS tools to monitor shift performance. 

• Submits Work Orders Notifications in SAP and contacts shift Equipment Technicians 

• Completes Non-Validated NRI’s and ensures proper documentation and covers breaks inside the fill room 

• Completes Documentation review of BFR’s and departmental logbook and facilitates BFR corrections  

• Acquires manager/designee review qualification  

• Completes testing of process related filters.   

• Performs routine inventories and escalates missing equipment/materials to management.   

• Consults schedule on a routine basis and ensure all parts and materials are available.   

• Trained on SAP and orders components as needed.   

• Training of all new technicians.   

• Ensures segregation of components.   

• Updates boards for OMS and works closely with managers to identify and close irritants 

• Participates during routine Gemba’s of work areas 

• Performs production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs. Must ensure maintenance of gowning and Physical dexterity. 

• Completes tasks and corresponding documentation as required by cGMP to ensure document completion (BFRs, logbooks, forms, etc). Works to prepare assigned areas for the oncoming shifts to ensure continuous operation and staffing. This includes assurance of all aseptic materials. 

• In on time and attends and participates in Shift Change. 

• Must be able to be complete and maintain qualification of utility sampling of WFI, Clean Steam, and DI as required to keep building GMP. 

• Participates or leads in all aspects of production process (SAP, Labware if required, Trackwise, RT Reports, eDoc, HMI, SCADA access, Virtual Standards, etc.). 

• Works to resolve all production issues.  Understands next steps and works to guide others through the process to complete them. 

• Ensures operational area is always adequately staffed. 

• Strive to become experts in their assigned areas 

This role is for a nonexempt employee working in the Filling Department. Their Bi-weekly pay is based on previous experience and education time.  

Their responsibilities are, but are not limited to: 

Safety: 

• Follows all procedures put into effect to ensure your safety as well as the safety of others.  Participates in monthly safety meetings. 

• Reports all safety issues, concerns, incidents and near misses to the team leadership. 

• Actively participates in safety walkthroughs coordinated by the department’s safety team. 

• Provides input for potential safety issues as well as contributing ideas for corrective and preventative actions. 

• Follows effective procedures to ensure the production of a safe and efficacious product. 

• Utilizes QDCI boards for Safety issues 

Quality: 

• Regulatory audit understanding and awareness. Point of contact for training discussions for regulatory and internal inspections.  

• Completes Shop Floor Gemba walks. 

• Point of contact for training initiatives within Filling. 

• Point of contact for all training change control and CAPA action items. 

• Ensures document revisions, logbooks, and forms are maintained as the correct revision on the production floor. 

• Understands the function of the quality group and works with them to maintain a positive rapport. 

Delivery: 

• Supports production in accordance with volume fluctuation, business need, and effective procedures. Must be flexible to ensure staffing for changing business volume and needs. 

• Completes all assigned training 

• All other duties as assigned. Adheres to all other company time keeping and attendance policies. 

• Ensures proper Aseptic technique is followed 

• Completes all SAP transaction is completed in real time 

Cost: 

• Executes procedure as documented to avoid deviations. 

• Utilize OMS appropriately 

• Works to resolve common production issues 

Involvement: 

• Works to become trained in all assigned training modules. Attends the daily shift change. 

• Trains and orients new team members (at any level) as assigned.  

• Participates and leads team meetings.  Understands respect, professionalism and confidentiality.