Quality Specialist I, Training
Overview:
Who we are.
Dendreon is making the battle against cancer personal. Our flagship product PROVENGE^® (sipuleucel-T), was the first FDA approved immunotherapy for the treatment of metastatic castrate resistant prostate cancer and is made from the patient's own immune cells.
If you are looking to positively impact the lives of patients, we want you to join our team. We have Immunotherapy Manufacturing Facilities located in Seal Beach, CA and Union City, GA. A sizeable Research & Development group based out of Seattle, WA, and a highly skilled Commercial team countrywide.
Core Values:
- Put Patients First. Every day is a new opportunity to improve the lives of patients living with cancer
- Act with Integrity. Be honest, transparent, and committed to doing what’s right in every situation.
- Build Trust. Building trust takes time. Engage teammates, be candid and transparent. Over communicate and seek feedback.
- Raise the Bar. Harness continuous improvement, foster innovation and elevate our people.
- Drive Results. Be accountable and execute – we win together when everyone performs.
Your Role: The primary role of the Quality Specialist I, Training will be to provide training 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.
Responsibilities:
Your Work:
- 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
- Provide archive and inspection readiness support when required.
- Perform other projects and duties as assigned.
Scope:
- Participates in decisions that have site/corporate implications
- Assures all solutions have a positive impact on the business from a compliance, financial and customer service perspective
- All documents and decisions are reviewed in accordance with applicable regulations, SOPs and regulatory bodies
Qualifications:
Job Requirements:
- Bachelor’s degree in Science, Education, or equivalent, or equivalent experience, with experience working in a biopharmaceutical environment.
- A minimum combination of 1-3 years working in a Quality/Compliance, Training, Operations, or Regulatory organization is required
- Experience working with an e-learning software is preferred
- Must be detail-oriented (e.g. accurately enter data) with excellent written & oral communication skills.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of cGMP and applicable FDA regulations is required.
- Proficient in MS Word, Excel, Outlook, PowerPoint and Project
Working Conditions and Physical Requirements:
- Ability to gown aseptically and stand when gowned in controlled manufacturing areas.
- Must be able to lift 25 lbs at a time and occasionally lifting or carrying articles such as files or banker box of documents
- May be required to use repetitive motion frequently of hand, finger, and wrists for the purpose of typing, data entry, and manipulating computer mouse