Job Description

This position will be responsible for the design and implementation of GxP training curriculum(s) for designated areas within Sharp Clinical Services Bethlehem.

The Training Specialist supports the Bethlehem site Quality department and Site Leadership in the direction, planning, and implementation of all centralized training and development initiatives across Sharp employee segments.

This position will design and implement effective training programs in conjunction with department heads aligned to the training strategy of supporting Sharp culture, business models and organizational needs while enhancing the skills and capabilities of employees. This position will also establish an environment that creates a service culture aligned to positive business results and business structures.

Essential Duties and Responsibilities

• Responsible to work with designated areas(s) 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.
• Providing hands on training and on the job training (OJT) when appropriate.
• Managing 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 maintenance and update of the GMP training program for new and existing staff according to cGMPs and Sharp procedures.
• Responsible to maintain Training program and training records in an inspection ready state.
• Responsible to identify training gaps through critical review and assessment of current training processes for effectiveness and making modifications to training curriculum and qualification requirements to improve demonstrated effectiveness.
• Responsible to provide periodic training status updates and reports.
• Responsible to coordinate internal meetings/training with Supervisors.
• Must be flexible to meet the needs to the organization relative to off shift training when required.

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The requirements listed below are representative of the knowledge, skill, and/or ability required.

• Bachelors’ 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)
• Experience with 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.