The Training Specialist will develop and execute training programs to support the stability and growth of our Production environments.
Perform tasks as assigned to increase the knowledge and understanding of GMP and Production processes.
Current programs include New Hire Orientation, Train the Trainer and Quality System (QSR) initiatives, etc.
Develop and maintain current programs and materials and develop new programs as future needs are identified from cross-functional sources.
Specific Duties and Responsibilities • Develop & maintain current training materials
• Present information using a variety of instructional techniques, tools and formats
• Conduct and/or co-facilitate professional development, computer skills, software orientation and training programs for employees
• Co-ordinate support, facilitate and grade written and microscope exams during company job fairs
• Train and test personnel for proficiency in manufacturing medical devices per Penumbra's Quality System
• Provide training on SOPs, WIs and Quality System requirements to incoming product builders
• Co-ordinate required training with cross functional groups as outlined by ECOs for changes to SOPs, WIs and MQIs in the manufacturing area
• Complete verification of training records for completeness and accuracy
• Respond to training record inquires via the Service Now Help Desk System
• Collect, organize and deliver data using Microsoft Excel, PowerPoint and TurningPoint software
• Drive resolution of process and/or documentation issues including origination and implementation of change requests
• Maintain clean room standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program
• Responsible for completion of personnel training records
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understand relevant security, privacy and compliance principles and adhere to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.
Position Qualifications • High School or GED with 5+ years of manufacturing experience in the medical device, pharmaceutical or biotech industry, or an equivalent combination of education
• 2+ years of learning and development or training experience
• Strong verbal, written and interpersonal communication skills
• Basic math skills are required, as well as proficiency with Microsoft Word, Excel, Access and Power Point
• Strong attention to detail, organization and teamwork skills
• Basic knowledge of cGMP/QSR requirements preferred
Working Conditions • General office, laboratory, and cleanroom environments.
• Willingness and ability to work on site.
• Potential exposure to blood-borne pathogens.
• Requires some lifting and moving of up to 25 pounds.
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a computer or other standard office equipment, such as a printer or copy machine, for an extensive period of time each day.
• Must be able to read, prepare emails, and produce documents and spreadsheets.
• Must be able to move within the office and access file cabinets or supplies, as needed.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.
Starting Base Salary is $66,560/year - $86,399/year. We offer a competitive compensation package plus a benefits and equity program, when applicable. Individual total compensation will vary based on factors such as qualifications, skill level, competencies, and work location.
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