Training Specialist

Essential Duties And Responsibilities

• Work with designated areas including Packaging, Logistics, Quality and Analytical Services to identify critical job roles and/or tasks requiring training.
• Design curriculums for identified roles, define training requirements for each curriculum and design qualification requirements, criteria and assessments for associated curriculums.
• Provide hands-on training and on-the-job training (OJT) when appropriate.
• Manage GxP training including new hire and annual GMP training.
• Work with Quality Systems group to develop process and best practices for managing the GMP training program.
• Work with Quality Management to develop process and best practices for maintaining and updating the GMP training program for new and existing staff according to cGMPs and Sharp procedures.
• Maintain Training program and training records in an inspection-ready state.
• Identify training gaps through critical review and assessment of current training processes for effectiveness and make modifications to training curriculum and qualification requirements to improve demonstrated effectiveness.
• Provide periodic training status updates and reports.
• Cook up internal meetings/training with Supervisors.
• Must be flexible to meet the needs of the organization relative to off-shift training when required.

Qualifications

• Bachelor’s Degree, Associates Degree, or equivalent in science or technical related field preferred.
• Minimum 5 years relevant work experience in a cGMP (food, drug, device or similar regulated) environment.
• Advanced knowledge of GMPs, GDPs, Auditing and Quality Assurance/Quality Control/Quality Systems skills and the ability to communicate this knowledge to the organization professionally and succinctly.
• Advanced ability to organize and conduct training sessions which may involve speaking/presenting in front of large audiences or via Microsoft Teams or similar platform (i.e. Zoom).
• Veeva Vault QualityOne desired.
• Demonstrated ability to work independently, handle multiple tasks simultaneously, negotiate and meet critical timelines, strong attention to detail and excellent organizational skills.
• Experience with Microsoft Office applications and quality management systems.
• Demonstrated ability for effective communication, teamwork, and problem-solving skills.
• Quality experience in an operational or development setting with demonstrated knowledge of techniques for assessing the quality of processes and the ability to guide others in these activities.
• Has adequate emotional intelligence to handle a variety of situations professionally and in accordance with regulatory compliance.
• Experience within a manufacturing, packaging and laboratory environments and associated equipment.
• Outside certification of basic quality skills and practices (i.e. ASQ, CQIA, CQI, CQT, etc.) is desirable.