The Training Specialist is a role within the Manufacturing Department that will collaborate with Production leaders and the Quality department to ensure effective delivery of training to production operators and to steward GMP compliance for training. The position will play a vital role in promoting and implementing onboarding and training that supports the employee experience and drives organizational goals, including cross training initiatives and sustainable approaches to maintaining qualifications. The Training Specialist will have focus that emphasizes the on-the-job (OTJ) training experience for production operators, particularly for critical operations qualifications, and will develop plans to ensure operational readiness regarding personnel training to ensure the operations teams are able to adhere to the production schedule.

Duties and Responsibilities

• Work hands on in the ECA building products for manufacturing
• Assembling components, inspecting product on the manufacturing line
• Develop, review, and revise training material such as On-the-Job Trainings (OJTs), PowerPoint presentations, and training documents in compliance with Good Documentation Practice (GDP) requirements
• Coordinate, conduct, and document training sessions as required on Standard Operating Procedures (SOPs) and Work Instructions (WI)
• Update/ red-line manufacturing process instructions/routers/forms using MS Word as required
• Identify and prevent gaps in training and production coverage
• Perform weekly and monthly audits of manufacturing area based on established standards and guidelines
• Solicit training evaluation from Manufacturing and Production personnel to identify areas for improvement in training process
• Collaborate with Quality and Operations team to implement process improvements
• Provide technical support to Production personnel and the production line as needed
• Assess variety of training offering methods and requirements of employees, support evaluation of training
• Assess employee skills and provide feedback to management
• Collect and analyze training metrics and identify potential projects/solutions for improvement
• Support investigations and NCR/CAPA closures for training-related items
• Specific duties will vary with availability, requirements, and priorities

Qualifications

• High School Diploma or GED and a minimum of 4 years of experience in operations or manufacturing with at least 2 years as an instructor in a medical device company
• Able to read and interpret work instructions, process routers, process specifications, technical manuals, written instructions, test procedures, etc.
• Experienced in/familiarity with training systems or programs
• Excellent technical assembly capabilities and exceptional track record in production, preferably with disposable catheter assemblies
• A firm understanding of Good Manufacturing Practices (GMP) and quality system requirements
• Ability and experience in analyzing, designing, and developing training materials
• Embody the Access Vascular Guiding Principles
• Teamwork, flexibility and adaptability to change
• Excellent data presentation skills
• Excellent written and verbal communication and skills
• Self-initiator with strong organization skills
• Basic level of competency with MS Word, Excel and preferably PowerPoint

PHYSICAL DEMANDS

The physical activities described within the job posting are representative of those that must be met by an employee to successfully perform the essential functions of this job.

Access Vascular, Inc is a proud Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status or disability status.