Jose G. Rolon Jimenez

Responsible for preparation and assisting the operation in an aseptic biologics processing following established Standard Operating Procedures (SOPs), Master Batch Records and Good Manufacturing Practices (GMPs). Processing work is performed in a ISO 7 clean environment. · Operates manufacturing equipment such as centrifuges, biological cabinet, incubator and -20 freezers, steam autoclave and oven. · Responsible for facility and equipment cleaning and for tools cleaning and autoclave. · Responsible for receiving human blood-derived component units and moving units to freezer to ensure material quality. · Ensures plasma blood-derived component and products are properly stored according to SOPs, which could include unsuitable units and samples

Responsibilities

• Job Description Perform production line duties required to meet production goals while complying with quality standards and safety requirements

• Operate production equipment and complete documentation in accordance with cGMP’s and department SOP’s while monitoring product to ensure quality standards are maintained

• This position is responsible for one or more of the following duties or activities: Maintain a clean and organized work area during and at the end of each shift

• Assist in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies

• Perform all assigned duties according to departmental SOP’s and cGMP’s

• Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department

• Complete and remain current with all required cGMP and safety training

• Perform tasks in the production / packaging of product to provide on-time delivery to customers

• Assist Maintenance Technicians with basic mechanical adjustments as needed

• Perform set-up and changeovers on production / packaging equipment

• Troubleshoot equipment and coordinate corrective actions to reduce or eliminate defects, rejects, or equipment downtime

• Complete all required documentation associated with the production and / or packaging of product

• Assist daily production in operating and monitoring technical computerized, production machinery ensuring quality standards are maintained

• Perform other duties as assigned

• Effective and efficient operation of manual and automated production equipment

• Provide guidance and training as required

• Ability to use, clean, and store tools and other devices required for the performance of the job in a manner which prevents damage to the tools and / or equipment

• Responsible for operating fast-paced machinery with all aspects of operating line and maintaining processes within prescribed specifications in a large manufacturing environment
• Functioned as materials handler, case packer, palletizer and stretch wrapper
• Monitored process cleanliness of line and shared responsibility for overall product quality and goals
• Ensured accurate and timely submission of daily paperwork
• Adhered to and enforced compliance with all safety procedures, policies and maintained good housekeeping standards at all times

• Responsibilities involved painting and fixing concrete walls as a contractor with a local staffing agency