Training Specialist

This position is responsible for the development, design, coordinating and implementation of GxP training along with assisting in developing and designing curriculum(s) for designated areas within Sharp Clinical Services Bethlehem. This role assists with maintaining compliance of the site regarding global and site-specific Quality objectives.

The Training Specialist supports the Clinical US 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, but not limited to, 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 site training including but not limited to new hire orientation, annual GMP training, Regulatory Audit readiness as well as other Quality topics.
• 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.
• Develop new trainings to refresh the site on particular topics to assist in ensuring competence and compliance across the site through different training tools.
• 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.
• Occasionally assist Quality Systems with data management and troubleshoot within QualityOne and document storage/retention/retrieval.
• Must be flexible to meet the needs to the organization relative to off shift training when required.
• Adhere to policies, processes and SOPs to ensure compliance with cGMP, FDA and any other regulatory regulations and safety standards.
• Participate actively in regular meetings.
• Achieve expected performance measures.
• Other duties as assigned

Qualifications

To perform this job successfully, an individual must be able to perform each essential duty. The minimum requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 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.