Jul 10, 2019

Quality Assurance Training Specialist - E-Learning

  • Paragon BioServices, Inc.
  • Harmans, Severn, MD 21077, USA
Full-time Education Curriculum

Job Description

Paragon Gene Therapy, now a part of Catalent, hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives.

Paragon Gene Therapy, in Baltimore & Harmans, Maryland, provides industry-leading GMP development and manufacturing services for cutting-edge biopharmaceuticals such as recombinant viral vectors, next generation vaccines & hard-to-express recombinant proteins and oncolytic viruses.

The GMP Training Specialist is a member of the Quality Assurance Training Program of a Contract Development & Manufacturing Organization (CDMO) performing research, process development and GMP manufacture of biologic bulk drug substances and sterile finished products. The core responsibility is to help GMP employees cultivate their skills and knowledge to maintain regulatory compliance. This role is also responsible for developing and providing training presentations with subject matter experts on relevant topics, providing measures to ensure complete understanding/proficiency, and performing/coordinating remedial training as applicable.

The GMP Training Specialist is an experienced educator whose abilities to convey a message should only be surpassed by a deep knowledge of your field. Organizational skills and a positive attitude are important qualities that this individual must possess.

The goal of the GMP Training Specialist is to promote efficiency and competitive advantage by developing the employee skill sets. The GMP Trainer is also responsible for maintaining the lifecycle of the Quality Assurance Training Program and evaluating for continuous improvement. The E-Learning Specialist develops graphics and animations that illustrate critical concepts and desired learning outcomes. They secure that media and learning methods are consistent with the audience location, learner profile, learning outcomes and training program content. The E-Learning Specialist selects media and graphical treatment that is consistent with both technology infrastructure and learning audience. They must possess advanced skills with eLearning tools and technology, videos, graphics, animation and audio development software.

Shift work and/or weekend work may be required at times.

Key Roles & Responsibilities include but are not limited to:

  • Provide strategic oversight of the training program and system.
  • Liaise with all department management at Paragon to determine training needs, establish training curriculums and assignments based upon work functions, and schedule training sessions.
  • Develop and deliver training presentations on pertinent topics to large groups of personnel on an as needed basis, including new employee orientation, annual refresher training, remedial training and on as a needed basis to support the production schedule. Examples include, but are not limited to, current Good Manufacturing Practices (cGMPs), Good Documentation Practices (GDPs), Aseptic Processing, Client Confidentiality Training.
  • Design effective training programs
  • Prepare educational material, such as, module summaries, videos, etc.
  • Support and mentor new employees
  • Keep attendance and other records
  • Maintain databases and systems to track required training records
  • Conduct evaluations to identify areas of improvement
  • Monitor employee performance and response to training
  • Assist processing and maintaining employee training files
  • Works with e-Learning team, instructional designers, trainers, and content experts to identify, develop, and implement customized e-Learning solutions that support learning strategies and objectives.
  • Develops videos, graphics, or animations that use cutting edge theories and technology to cover critical concepts and adhere to desired learning outcomes in an online or on demand setting.
  • Selects media and graphical treatment that is consistent with technology infrastructure and learning audience needs.
  • Consults with an Instructional Designer on media and methods that are consistent with the audience location, learner profile, learning outcomes and training program content

Experience & Education:

  • Bachelors degree preferably in eLearning, Film, or Graphic Design
  • 5 years of experience with a role in e-Learning development. Core responsibilities in that role should include development of courses or online multi-media content using video, animations and graphics applications.
  • High degree of proficiency in Articulate Storyline required
  • Experience in video development desired
  • Graphic Design experience preferred
  • Familiarity with electronic systems, including Master Control Learning management systems and Excel
  • Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks
  • Experience supporting regulatory CGMP, ICH and EU compliance is a plus

Paragon Bioservices is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.


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