Joseph Fisset

Ensuring continuous supply of medicines by expertly running processes, troubleshooting, and collaborating cross-functionally.
Providing leadership on the manufacturing floor to maintain safety, quality, and productivity.
Maintaining a safe work environment and supporting Health, Safety, and Environment (HSE) goals.

Excellence:
Operating equipment and performing activities to meet production schedules.
Checking execution documentation (e.g., Electronic Batch Record, SAP, Cleaning Logs).
Driving departmental objectives, including improving safety performance, reducing deviations, enhancing productivity, and ensuring training compliance.

Ensuring Safety and Quality:Maintain a safe work environment and exemplify safe working practices.
Support Health, Safety, and Environment (HSE) goals.
Ensure compliance with quality systems and procedures.

Operational Excellence:Operate equipment and perform activities to meet production schedules.
Troubleshoot issues and escalate them as needed.
Check execution documentation, including Electronic Batch Records, SAP, and Cleaning Logs.
Drive departmental objectives such as improving safety performance, reducing deviations, enhancing productivity, and ensuring training compliance.


Operational Support:

Perform tasks related to formulation, aseptic isolator barrier filling, and equipment preparation.

Operate equipment and execute activities to meet production schedules.

• Generates, distributes and controls the utilities/WTP operations used in support of R& D and production of products.
• Operates, observes and assists in the control and operation of the utilities and WTP plant. This includes starting, stopping and adding treatment chemicals to the plant Boilers and Chillers in order to maintain and optimize systems and plant performance.
• Monitors operations recording all appropriate data accurately. Complete assigned tasks such as lab testing, sampling, and field testing. Monitors equipment operations and report problems
• Participates in the troubleshooting and response to situations and acts as directed regarding Equipment or systems to ensure safe and reliable operation
• Reports alarms and problems and takes actions as directed to resolve issues.
• Effectively communicates operating status to other shifts and management as needed to maintain efficient operation.
• Accurately enters shifts information into shift log books and required log sheets.

• Received in and approved all drug material and ancillaries
• Successfully processed deduct and re-receipt activities
• Performed quality checks on product to ensure accuracy of labeling and cosmetics.
• Reviewed inventory regularly to purge aging inventory
• Operated forklift to move material within the warehouse
• Provided van delivery service for analytical and file samples
• Performed yearly physical/inventory/cycle counting activities
• Reviewed various reports and records for temperature storage compliance
• Packaged and shipped clinical drug products for domestic and international shipping utilizing FedEx Purolator and clinicopia software

• Performed all functions related to particle manufacturing and processing including
• Particle sonicating, sieving and washing.
• Filtration, decanting, and centrifuging.
• Operated glass reactors, charge pots, centrifuges, and pumps
• Operated sieves, screen cleaners, sonicators, tumblers, drying ovens and mixers.
• Prepared samples for quality analysis and R&D following protocols, studies and manufacturing documentation
• Performed complex computer data collection and analysis.
• Responsible for labeling storage, inventory and movement of materials.
• Provided general calibration assistance of equipment used in manufacturing.
• Performed all duties using good manufacturing and documentation practices
• Assisted in training new employees

• Perform line clearance and set up of finishing room for production.
• Perform periodic quality checks to determine product is of upmost quality.
• Operate and perform maintenance on Automatic Packaging Equipment.
• Pull, document and package daily processing samples needed for quality assurance.
• Use micrometers and calipers to assure product is within specification.
• Operate forklift to retrieve product from incubation room to production area as needed.
• Enter daily production processes into POMS computer system.
• Perform challenges using bar code cards on machines to ensure scanners are reading correctly.
• Set up production labels for Lot, Exp Date, and batch codes using off-line computer.
• Oversee 10-12 Production Associates to schedule line rotation, breaks, and resolution of production issues.

• Hospira, North Chicago, IL
• Worked in a team-based environment to manufacture small batch sterile solutions; process tested pH samples that were scientific in nature for use in the pharmaceutical industry
• Implemented production-manufacturing procedures to optimize processes and meet regulatory requirements
• Carried out standard operating procedures (SOP) involving complex laboratory techniques, calculations, materials measurement, operation of laboratory equipment and record keeping necessary to manufacture products, that included Production Batch Records, notebooks, and work order documents
• Used Flowstream software; inspected Bills-of-Materials (BOM) to ensure correct materials were being ordered and used
• Utilized specialized technical knowledge and skills to make detailed observations and analyze data to ensure within operating parameters. Troubleshot, identified and resolved problems in processes
• Completed production and quality analysis of reagents, components and finished products in accordance with the Production Schedule. Suggest options for process improvements
• Calibrated and maintained equipment, product inventories and related records as assigned; noted variances on manufacturing documents; audited and evaluated process documents and proposed revisions
• Identified and implemented manufacturing procedures intended to optimize existing processes and ensure achievement of regulatory requirements that targeted improvements in product yield and reduced manufacturing time and cost
• Maintained assigned area in a high degree of cleanliness and assure compliance with established housekeeping standards.
• Assured associates were properly trained in critical areas of safety and housekeeping, team behavior, time management, lean manufacturing, conflict resolution, continuous improvement and total quality management.
• Actively participated in troubleshooting and variable identification for specific processes or activities as assigned and reported findings to team management and members with recommendations for improvement
• → Championed continuous improvement initiatives by identifying areas for process and system improvements to achieve targets for operational excellence; Contributed to monthly group meetings on how to improve production and quality
• → Certified Drug Agent (CDA) responsible for monitoring and signing for all incoming and outgoing government controlled drugs
• → Certification of Fellow Employees (CFE); certified to give safety presentation to fellow employees
• → Served as member of the Quality Team and Safety Team