QA Specialist III (Training)
Description
Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx has two commercial products approved in the United States, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor). Ardelyx has agreements for the development and commercialization of tenapanor outside of the U.S. Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan. A New Drug Application for tenapanor for hyperphosphatemia has been submitted in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada.
Note: Contractor hiring to full-time Conversion targeted within 3-6 months post start date.
- Provide day-to-day administrative support for Electronic Document Management System (EDMS) and Learning Management System (LMS)
- Controlled documents (such as Policies, SOPs and Work Instructions) and Document Change Control related processes
- Periodic review of the controlled documents per SOP requirements
- Oversee company wide Training Program. Ensure appropriate training requirements are defined for all job roles and training records are readily retrievable
- Write, maintain and implement policies and supporting SOPs, Work Instructions/Forms and training materials for the Training Program
- Conduct orientation training for new hire employees
- Perform Change Control activities associated with the Training Program
- Complete daily workload while maintaining consistent, right first-time quality work and compliance with established procedures and timelines
- Identify and implement efficiency and compliance improvements to the training and controlled document management process
- Support Product Quality Complaint handling activities.
- Support internal deviation and CAPA processes
- Support the reporting of Quality metrics on a weekly, monthly, and quarterly basis
- Support Vendor Management
- Perform other related duties as assigned from time to time based on company needs
- Bachelors’ or higher degree in sciences
- 3 - 5 years experience in a Quality environment, with exhibited knowledge and proficiency of Quality System requirements
- Practical understanding of CFR Title 21 (Parts 11, 210, and 211)
- Understanding and familiarity with FDA regulatory requirements, guidelines, and recommendations for product complaints
- Broad experience with Quality Assurance systems and processes
- Proficient with technical, problem solving and project management skills
- Excellent communication and organization skills required
- Ability to speak, present data, and defend approaches in front of audiences and inspectors
- Experience and proficiency with industry standard enterprise system applications (QMS, EDMS, LMS)
- Proficiency with word processing and spreadsheet
- Knowledge of Good Documentation Practices (GDP)
- Ability to work in a highly detailed environment where mental focus and accuracy of timely work output is essential