Quality Assurance Specialist III/IV

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. 

• Support the reporting of Quality metrics on a monthly, and quarterly basis in support of Management reviews and KPI 
• Support various quality risk management frameworks 
• Perform batch record review and product dispositions in support of clinical trials, registration, validation, and commercial product distribution  
• Evaluate compliance of completed manufacturing records (batch records, COC/ COA, and any related data as applicable) from CMO as necessary to ensure that they are accurate and complete
• Maintain Continued Process Verification data collection in real-time at batch release 
• Review all the supporting documents regarding Quality System documentation including deviations, OOS, product complaints, CAPAs, and document /change controls-related processes
• Evaluate document changes for compliance requirements (SOPs, Master Batch records, etc.) 
• Support the analysis and reporting of product and process quality trends, and quality system performance against internal and external guidelines, standards, and regulations
• Support QA CMO oversight activities to ensure required quality standards are maintained
• Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
• Collaborate with CMC to continually improve compliance with quality systems, internal SOPs, and regulatory requirements and to resolve minor and major deviations
• Support Product complaint-handling activities. 
• Support the Annual Product Quality Report preparation
• Support cGMP compliance audits of GMP suppliers’ quality systems
• Support and conduct training for employees, as necessary
• Perform other related duties as assigned from time to time-based on company needs 

• Bachelor’s degree in science or equivalent relevant experience
• 7+ years of combined GxP experience in drug substance and drug product manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
• Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
• Working knowledge and/or understanding of quality risk assessment management principles 
• Extensive knowledge of GMP regulations and guidance (such as US, EU, and ICH)
• Extensive experience with Quality Assurance systems and processes
• Effective organization and planning skills
• Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills
• Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Veeva (a plus)) and demonstrated troubleshooting and problem-solving techniques
• Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups
• Proven ability to work independently and under tight deadlines and pressure in a composed manner
• Effective interpersonal and communication skills
• Comfortable communicating with all levels of staff, including executives
• Strong team player

Location

•  Remote