Jason Althoff Email & Phone Number

St. Louis, MO, US

Greater St. Louis Area

• CAPA subject matter expert: investigation guidance, coaching and coordination for all aspects related to the initiation, tracking, trending and management of all manufacturing and investigations, CAPA evaluation and.
• Strong track record as an interdepartmental Compliance collaborator: Working with Site Leadership, Production Management, Quality Assurance, and Regulatory to facilitate consistent, disciplined execution of the CAPA.
• Sought after technical writing skills: Drafting and redline assistance for departmental standard operating procedures and work instructions, as well as drafting of records for Notifications to Management and/or Field.
• Determined patient care champion: Unwavering leadership and convictions within assigned CAPA investigations, projects, and tasks to ensure excellence in product quality and patient safety.
• Project and investigation management driver: Demonstrated ability to manage multiple CAPA investigations and associated tasks across multiple departments with little to no oversight, and within product release and.
• Servant style leadership: Leader amongst peers who fosters a collaborative and fun atmosphere within department, leading cross-functional teams, or supporting leadership of teams I am placed on.

Greater St. Louis Area

• Supervision of up to 70 colleagues on the production floor within all manufacturing areas.
• Peer leadership, coaching, and training of all Production Supervisors on staff.
• Coordination of planning activities in conjunction with manufacturing and warehouse management surrounding 20+ product types to meet market forecasts.
• Pfizer Six Sigma Green Belt and Yellow Belt training followed by serving as Supervisory Lead for Method 1 problem solving within manufacturing.
• Assist Operational Excellence and Compliance groups with systematic problems solving within CAPA system regarding site opportunities for improvements within training, quality and manufacturing processes and systems.
• Selected by Site Leadership as Project Lead over new production line implementation with oversight of all commissioning activities including equipment installation, validation qualification, documentation.

Spencer, IN

• Supervision of up to 35 Production Trainers on the production floor within all training capacities.
• Measure and continually improve effectiveness of training and development initiatives.
• Assist in the design and development of behavior-based training programs.
• Create training materials utilizing Microsoft Powerpoint, Word, Excel, Adobe Captivate within site Learning Management Systems.
• Write and approve CAPA Change Requests through the Product and Data Management System (PDM).
• Site Training Record System (TRS) administrator and trainer.

Spencer, IN

• Assist Manufacturing Engineers in the design, development, documentation, prototyping, testing, validation and implementation of new/improved medical devices and related manufacturing processes.
• CAPA System: Subject matter expert in assigned area for all line support, preventative maintenance, corrective and preventative actions, and effectiveness checks for assigned manufacturing areas.
• Assisted in decommissioning of equipment and preparation for shipment as well as performing training and workshops with groups of employees who were flown in from Costa Rica to learn the equipment functionality and.

Newport, IN

• Government SECRET clearance and CPRP Green Bar per US Army Regulations.
• During Plant Closure – Assistant to Site Environmental Manager.
• During Operations – Assisted maintenance personnel with entry into air monitored toxic areas.
• Designated trainer within all assigned work area.
• Certifications: Toxic Area Training in Emergency Egress, OSHA 30 and Hazwoper 40 Hour Cards, OSHA VPP Star Status in Safety Excellence.

Terre Haute, Indiana Area

• Responsible for all Trainer-Led Performances and On-the-Job Training for Primary Operators.
• Job responsibilities include preparing, set-up, maintaining, cleaning and operating all clean room packaging equipment and components.
• Equipment included all Primary Blister Packaging equipment.
• Responsible for excursions, alarms, minor to medium maintenance, sensor challenges, component accountability, quality defects and troubleshooting of equipment in-process.
• Responsible for training all new employees in Orientation and on all machines and processes in area.
• Utilized as primary packaging resource and sole trainer on new powder equipment installation when additional packaging lines were being installed in 2007.

Pella, Iowa; West Columbia, SC

• Responsible for safety, quality, productivity, inventory, delivery and customer satisfaction within assigned Cost Centers.
• Continuous Improvement experience includes Kaizen and Managing for Daily Improvement.
• Managed up to 30 team members within each Cost Center and coordinated efforts among indirect team members.
• Other responsibilities included interviewing, hiring, training, evaluations and corrective action for team members in conjunction with the HR department.

Bachelor Of Science (B.S.), Christian Leadership

Bachelor Of Science (B.S.), Management Information Systems