Quality - Sr. Specialist, Instructional Designer

Innovation, Document management, Detail oriented, Microsoft Visio, Proactive, Computer based training, FDA Regulation, Documentation, CGMP, Curriculum Development, Training Design, Quality Management System, Instructional Design, Project Planning, Quality Control, Facilitation
Full Time
Depends on Experience
Travel not required

Job Description

Sunrise System Inc. is currently looking for Quality - Sr. Specialist, Instructional Designer in Devens, MA with one of our top client.

Job Title: Quality - Sr. Specialist, Instructional Designer 

Job Id: 21-09012

Location: Devens, MA 01434

Duration: 6 months

Position Type: Hourly contract Position (W2 only)

Job Description

  • The Sr. Specialist, Instructional Designer is a full-time position located at the Devens Cell Therapy Facility located in Devens, MA.
  • The primary focus for this role is to facilitate the development for instructor-led, on-the-job, and computer-based training courses that support the Devens Cell Therapy facility.
  • This role will provide coaching on training requirements, adult learning principles, curricula design support and alignment to local training processes and with global and / or regulatory requirements.

Required Competencies

Knowledge, Skills, and Abilities

  • Strong experience and an in-depth knowledge of cGMPs, cGTPs, and cGoogle Cloud Platforms and applicable Health Authority regulations / guidelines and industry best practices for supporting a training program
  • Instructional design experience incorporating adult learning principles and SMART training objectives
  • Strong experience and thorough understanding of global regulatory training requirements
  • Strong experience and an in-depth knowledge of adult learning principles
  • Capable of leading and working cross-functionally to support the training requirements associated with deviations, change controls, and CAPAs
  • Proven experience working as a detailed oriented team player with effective planning, organization and execution skills
  • Innovative, proactive, and resourceful; committed to quality and continuous improvement
  • Ability to work effectively at a fast pace with cross functional departments to finalize time-sensitive deliverables
  • Effective manager of project deliverables
  • Able to manage multiple priorities
  • Strong project planning skills
  • Strong computer skills with MS Office (e.g. Word, Visio and Excel) and with Quality Systems (e.g. Document Management System, Quality Management System

Education and Experience

  • Bachelor’s degree with 5 years minimum of Training & Learning experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA. (Master’s Degree specializing in Instructional Design is preferred).
    OR
  • High school degree or Associates Degree with 3 years or more CAR- T experience, 5 years minimum of Training & Learning experience, and more than 10 years of experience in a regulated environment

Duties and Responsibilities

  • The primary responsibilities of the Sr. Specialist, Instructional Designer are to ensure the effectiveness of training across the Devens Cell Therapy organization through the creative and compliant development of training programs that drive and support overall site effectiveness, increase associate skill sets, develop robust training programs that support the resolution of corrective actions and / or preventive actions while ensuring that these programs comply with the internal and regulatory training requirements.
  • Support, maintain, encourage, engage and empower a learning culture for trainees and for the Training and Learning Organization
  • Oversee projects from start to finish
  • Develop training programs that drive an increase in overall training effectiveness and the empowerment of CAR T personnel
  • Design and develop training courses using various instructional design and methodologies while incorporating adult learning principles
  • Contribute to the writing, review, approval and maintenance of metrics, and associated training Standard Operating Procedures (SOPs) or Work Procedures (WP)
  • Identify, evaluate and implement key performance metrics for training effectiveness and for business expectations regarding training design
  • Analyze training effectiveness data and lead improvement training and learning initiatives
  • Create engaging learning activities and compelling course content
  • Work with Subject Matter Experts to identify target audience’s training needs
  • Set instructional end goals and create content that matches them
  • Visualize instructional graphics, the user interface and the finished product
  • Create supporting materials/media (audio, video, simulations, role plays, games, etc.)
  • Devise modes of assessments, such as tests, quizzes, to measure the effectiveness of the course
  • Maintain and control electronic document content and folders as per good documentation requirements
  • Drive continuous improvement for training programs
  • Address recurring issues identified throughout Devens Cell Therapy for training
  • Ensure training documentation/files are maintained, with good documentation practices and in compliances with Devens Cell Therapy Quality Systems and retention programs
  • Work independently and perform with a high degree of accuracy
  • Partner with other members of Training teams across the organization to build harmony and alignment
  • Support internal and external Inspections

Contact

Satya 

Email:  Direct: . 

Dice Id : sunrise
Position Id : 21-09012
Originally Posted : 3 months ago
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