Quality Specialist I, Learning Management System and Training

Job ID 2020-1784
Job Locations
US-CA-Seal Beach
Category
Quality Assurance

Overview

Who we are.

Dendreon is making the battle against cancer personal. Founded on the belief that the immune system holds the key to the future of cancer care, Dendreon is committed to the delivery of treatments that harness the power of the body’s immune system to attack cancer cells.

If you are looking to positively impact the lives of patients, we want you to join our team. Headquartered in Seal Beach, California, and with sizable locations in Union City (Greater Atlanta), Georgia and Seattle, Washington, as well as countrywide Commercial and Medical Science Liaisons teams, we have a diverse offering of exciting opportunities.

What we do.

 

Vision – Pioneering the future of immunotherapy.

Mission – Making the battle against cancer personal through immunotherapy treatments that extend lives.

 

How we do it.

 

The Dendreon Way.  We are a purpose-driven, value-based culture. At Dendreon, we…..

  • Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer.
  • Elevate Our People. The strength of our company lies in the success of our team.
  • Drive Results. Be accountable and execute – we win when everyone performs.
  • Foster Innovation. Building a culture of creativity, and pushing past boundaries.
  • Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.

 

Are you ready?

 

Our high-performing organization challenges, develops, and rewards employees interested in pushing past typical career limitations. If you are passionate about helping patients and looking for a unique career opportunity, view our open positions to apply or refer a friend today.

 

Job Summary:   The Quality Specialist I, Training and Documentation position supports the day to day and strategic responsibilities of the Dendreon Training and Document Control Departments. 

Responsibilities

Responsibilities:

The primary role of the Quality Specialist, Training will be to provide training coordination support/ownership for the organization which includes tracking, reporting, executing, and building within the Learning Management System (LMS). These activities aid in remaining compliant to all applicable governing requirements/regulations. The Quality Specialist, Training will be a proficient training professional who is highly motivated and desires to take their organization and people skills to the next level.

 

  • Maintain and update training files through data entry into the LMS.
  • Audit and monitor data integrity within the LMS.
  • Provide LMS training and support to the organization which includes general cGMP training, on the job training, and environmental health and safety training
  • Assist with the development of training modules and delivery of training to company personnel.
  • Assist in the management of training curriculum and training plans
  • Coordinate training notifications for all company personnel
  • Compile training program metrics and build management reports
  • Perform Impact Assessments and execute Change Management related task
  • Assists in compiling corporate filing documents and maintaining computerized files to support all documentation systems, including controlled documents, technical documents, master equipment, manufacturing and CMO.
  • Assists the review and revision of procedures, specifications and forms.
  • Prepares process and status reports, assigns and monitors document numbers, and reviews documents for accuracy and completeness.
  • Assist in the development and maintenance of document filing systems for storage of controlled document.
  • Updates logs, databases and catalogues.
  • Provide archive and inspection readiness support when required.
  • Perform other projects and duties as assigned.

 

Scope:

  • Administers the Learning Management System 
  • Works collaboratively with personnel to maintain the training system
  • Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors. Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
  • Drives accountability and results through metrics
  • Ability to communicate with all areas of the business and all levels of personnel

 

 

Dendreon is an equal employment and affirmative action employer F/M/Disability/Vet/Sexual Orientation/Gender Identity.

The preceding job description has been designated to indicate the general nature and level of work performed by employees within this classification. Additional and incidental duties related to the primary duties may be required for company business needs from time to time.

Qualifications

Job Requirements:

  • Bachelor’s degree in Science, Education, or equivalent, with experience working in a biopharmaceutical environment preferred 
  • Training and/or Instructional Design certifications preferred
  • One to three years related experience in a cGMP/FDA regulated industry
  • Pharmaceutical or Biotechnology experience, Aseptic Technique and Clean Room knowledge requiredStrong verbal communication with customers, teams and management
  • Strong computer skills with Word, Excel, Outlook and PowerPoint are required
  • Experience with LMS systems required
  • Knowledge of e-learning/web-based technologies preferred
  • Ability to manage multiple priorities
  • Ability to work multiple shifts/weekends
  • Ability to network, share best practices and further develop skill level
  • Working Conditions and Physical Requirements:

  • Ability to gown aseptically for work in a Clean Room environment

  • May be required to work alternate shifts/weekends
  • Limited exposure to (2ºC - 8ºC); (-20ºC); (-75ºC) areas.
  • Must have the ability to work around laboratories, manufacturing areas and equipment, and regularly lift 10 – 20 lbs and lift up to 50 lbs

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