Quality Assurance Specialist III (CMC)

Ardelyx was 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), as well as early-stage pipeline candidates.

PURPOSE OF THE ROLE

The QA Specialist III will provide QA support for Quality Operations. Working in a fast-paced pharmaceutical environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual's abilities to carry out the assigned responsibilities. In addition, the position requires the candidate to possess strong document and change control management and quality risk assessment management experience, in a GxP environment.

POSITION RESPONSIBILITIES

• Manage change control records through completion
• 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

POSITION REQUIREMENTS

• 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) a plus
• 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