Quality Training & Development Specialist - Hybrid/Remote

POSITION SUMMARY:
Please apply online using a laptop or desktop computer.
The Training and Development Specialist - Clinical Quality is responsible for supporting quality oversight and support of Be The Match's clinical research program as well as developing, integrating, and assessing training programs and coordination between departments. This role works closely with business units, project teams, process owners, leaders, and subject matter experts (SME) to create training solutions related to quality systems in a cell therapy research and manufacturing setting. This position can be remote (US) or hybrid. #LI-Remote #LI-Hybrid
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ACCOUNTABILITIES:

• Applies instructional design principles (i.e., ADDIE) to assess learning needs, to design and develop instructional content, and evaluate the impact of learning solutions.
• Applies adult learning theory, participant-centered learning, and other learning theories.
• Produces learning solutions via various learning software tools.
• Adheres to regulatory requirements and NMDP Training Management and Competency Program for the design, delivery, and documentation of training, including release-to-task and competency assessment.
• Supports clinical department SOPs and process document creation and revisions
• Liaises with Be The Match Quality Assurance and Quality and Compliance Training to align with broad company quality goals and initiatives
• Maintains oversight and tracking of role-based clinical training curriculum
• Models teamwork and maintains a positive working environment
• Fosters a collaborative working relationship with other functional areas
• Supports operational metrics reporting
• Maintains a professional demeanor during all external interactions with physicians and study sponsor representatives
• Other duties as assigned

REQUIRED QUALIFICATIONS:
Knowledge of:

• Training quality and compliance in a regulated manufacturing setting.
• Thorough understanding of ICH Guidelines, GCP and FDA regulations.
• eLearning authoring tools (i.e., Articulate 360, Storyline, Elucidat)
• Electronic quality systems management.
• Knowledge of the clinical study development and execution pathway.
• Clinical operations and efficiencies.
• Drug development cycle.

Ability to:

• Develop effective instructional content through authoring software (Articulate 360, Storyline, Elucidat, Adobe, etc.).
• Communicate effectively in all situations with strong interpersonal and consultation skills.
• Establish strong working relationships with internal and external clients, using diplomacy to address conflict and resolve solutions successfully.
• Operate with a high degree of ethics
• Meet key deadlines and manage multiple projects and tasks simultaneously
• Write and communicate articulately and concisely.
• Work proactively, take initiative and ownership and assess risk.
• Problem-solve creatively.
• Must exemplify our Be The Match Standards

Education and/or Experience:

• Bachelor's degree or equivalent experience required, preferred in scientific or health related field, and minimum of 2 years of training and development experience.
• Demonstrated success experience in learning design, development, delivery, and evaluation.
• Minimum 2 years of clinical trials experience or 2 years' experience in a quality assurance position in a clinical/biotechnology/medical device field.
• Experience with reviewing and drafting GCP related documents such as SOPs and protocols.

PREFERRED QUALIFICATIONS: (Additional qualifications that may make a person even more effective in the role, but are not required for consideration)

• Experience working in a regulated/manufacturing environment strongly desired.
• Quality management system or clinical auditing experience.

Be The Match offers regular, full-time employees medical, dental, vision, life and disability, accident/critical illness/hospital, well-being, legal, identity theft and pet benefits. Retirement, paid time off/holidays, leave and incentive plans are also offered to eligible employees. Please reference this link for more information: Be The Match Benefit Information