Job Details

Assists Manager, Red Cell Processing with oversight of day-to-day operations of the department to achieve Quality, compliance, stability, and predictability in operations. Performs a variety of tasks and duties with a high degree of multi-tasking and attention to detail including appropriate product and component control, product handling and storage, inventory, training and developing of employees, and coordinating and scheduling operations. Processes red blood cells, formulates red blood cell products into a diluted (bulk) state, and performs in-process testing in an aseptic production environment. Performs production tasks in a cleanroom environment in compliance with Good Manufacturing Practices and Good Documentation Practices.

Job Summary

Facilitates and supervises production Processes in support of the Production Supervisor or Manager including, a variety of tasks associated with the manufacturing of Werfen products.

Key Accountabilities

• Provides guidance to Red Cell Processing staff members for daily lab operations.
• Trains new and incumbent staff members to achieve competency in lab functions and maintains up-to-date training records.
• Assists Manager and Supervisor with staff evaluation and development.
• Maintains department morale and employee motivation in a positive work environment.
• Monitors and maintains critical inventory of required supplies, components and raw materials.
• Assists in scheduling and performance of special projects and validation activities within the department.
• Performs blood processing operations according to corporate policies, operating procedures, specifications, and work instructions.
• Ensures blood products are transported, processed, and stored in a manner that prevents contamination.
• Follows appropriate control measures to prevent mixing of dissimilar production components in compliance with Good Manufacturing Practices.
• Performs in-process testing and visual inspections of product for defects.
• Creates legible written processing records that initiate product Batch Records and comply with all procedures and Good Documentation Practices.
• Follows applicable laboratory & OSHA regulations with respect to hazards and blood-borne pathogens.
• Maintains a neat, clean, and orderly work environment.
• Independently performs equipment setup, operation, re-supply, documentation, cleaning, minor adjustments and minor maintenance tasks to meet standards for safety, quality, reliability, and efficiency.
• Applies FDA regulations, and ISO standards to department operations and understands consequences of non-conformance.
• Moves, stores, and inventories production supplies and materials according to department specifications.
• Completes all training and qualification requirements; actively participates in on-going training and the training of new employees.
• Assist and communicate with co-workers to assure all safety, quality, and efficiency objectives are achieved.
• Demonstrate supportive behaviors towards co-workers and cooperate as a member of the team.
• Demonstrate behaviors supportive of personal and professional growth of self and co-workers.
• Assist with SOP revisions.
• Assists department improvements and validation activities.
• Serves as RBC Processing Department representation when designated by management.
• Assist with accurate inventory for the department.
• Supports and performs review of Manufacturing DHRs for RBC Processing, Solid Phase, VLP, Serum Bulk Manufacturing, and cleaning and maintenance records as needed.
• Performs BAAN entries (Production Orders, Material Transfers, BOMs) and data entry support, as needed.
• Assists in the development of metrics which help track manufacturing departmental outputs and effectiveness.
• Performs other duties as assigned by RBC Processing Management.
• Performs other duties and responsibilities as assigned.

Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions.

• Networking/Key relationships
• Works closely with other production (manufacturing) members, quality control, quality assurance, customer service, shipping, and marketing staff.

Minimum Knowledge & Experience required for the position:

Education: Degree/ diploma obtained, program of study or equivalent.

Experience:

Ability to speak, read and write English

Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.

Ability to work irregular hours as necessary to meet production schedules, assigned work shift, and occasional overtime, preferred.

Skills & Capabilities:

• Leadership & Team Guidance – Ability to supervise daily operations, support staff development, and maintain team morale.
• Technical Proficiency in Blood Processing – Knowledge of red blood cell processing, aseptic techniques, and cleanroom protocols.
• Regulatory Compliance – Understanding and application of GMP, GDP, FDA, ISO, and OSHA standards in a production environment.

Travel requirements:

N/A