Position Title: Specialist, Learning Systems & Compliance

Work Location: Seattle, WA

Assignment Duration: 6 Months

Work Schedule: Normal Business Hours

Work Arrangement: Hybrid

Top Skills:
• Minimum 2-3 years of experience in quality and compliance systems.
• Experience with EDMS and LMS required
• Experience with Deviations and or RCAs preferred
• Prefer minimum 1 year experience in learning and development
• Technical writing skills preferred

Position Summary: The Specialist, Learning Systems & Compliance plays a crucial role in ensuring compliance withing Global Patient Operations. This position focuses collaborating with our Learning Management System (LMS) partners to ensure effective deployment of training, support Change Management for Global Patient Operations as the single point of contact, supporting Deviations/CAPA investigations, and creating content based on proposed CAPAs.

Background & Context: We are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology, and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contributes to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference. Cell Therapy is one of the most groundbreaking new forms of cancer treatments being studied today. With therapies only in their infancy and our continued investment in our Cell Therapy capabilities, the growth potential of this science, and the ability to help patients are incredible.

Key Responsibilities:

• Data Reporting: Generate and maintain regular compliance reports to share out to Global Patient Operations leadership for streamlined communication
• System Integration: Work with IT and LMS administrators to integrate learning systems with other organizational tools and platforms. Actively engage in the identification, sharing, and adaptation of best training practices cross-functionally.
• Subject Matter Expert (SME): Create and maintain, as delegated, the Learning and Development governance documents (SOP/WI) in the DMS.
• Compliance: Ensure that training programs comply with relevant industry regulations and internal policies.
• Deviations/CAPAs: Support SCLT deviations and investigations to capture unexpected events and propose strategies to mitigate recurrence of events.
• Content Creation: Creating content based on proposed CAPAs as needed to fill training gaps as identified from root cause analysis (RCA) investigations.
• Change Management: Supporting contact for Global Patient Operations Impact Assessments. Attend CCRB Meetings to delegate Impact Assessments based on new proposed changes to capture needed improvements to processes and documents.

Qualification & Experience:

• Bachelor's degree in Education, Life Science, Technical Communication, or a related field
• Minimum 2-3 years of experience in quality and compliance systems. (7 + yrs experience overqualified, PhD overqualified)
• Excellent verbal and written communication skills.
• Technical writing skills
• Excellent project management and organizational skills.
• Prefer minimum 1 year experience in learning and development
• This position requires up to 10% of travel.

 
 
At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position’s starting pay is: $ 44.89/hr.