QA Specialist III

Ardelyx•Newark, CA

7h•$113,000 - $129,000•Hybrid

About The Position

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 approved in China with Fosun Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: The QA Specialist III will administer QA ongoing projects for Quality Operations. Working in a fast-paced pharmaceutical environment with a broad scope of responsibilities, this position will bring many different skills to the job, with a focus on achieving QA milestones. This role will ensure manufacturing or processes adhere to compliance or industry standards by possessing strong document, quality risk assessment management, and CMC QA skills, in a GxP environment. This will be a hybrid position based out of the Newark, CA office.

Requirements

Bachelor’s degree in science or equivalent relevant experience with 5+ years of combined GxP experience in process development and commercial in biotechnology or pharmaceutical industries or equivalent experience
Experience in relevant CMC area (DS, DP) , with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes
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 FDA, EU, and ICH)
Experience with Quality Assurance systems and processes
Excellent investigational and QA problem-solving skills
Demonstrate ability to deal with frequent changes, delays, or unexpected events
Strong technical writing skills
Advanced software skills including SharePoint, and Veeva
Proven ability to work independently and under tight deadlines and pressure in a composed manner
Effective interpersonal and communication skills, and teamwork oriented
Comfortable communicating with all levels of staff, including executives

Responsibilities

Perform batch record review and product disposition in support of clinical trials, registration, validation, and commercial product distribution
Evaluate compliance of completed manufacturing records (batch records, COC/ COA, packaging, and any related data as applicable) from CMO as necessary to ensure accuracy and completeness
Collaborate with CMC to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process
Review development, and validation protocols and reports
Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements
Provide QA CMO oversight activities to ensure required quality standards are maintained
Retrieve data to support the reporting of Quality metrics on a quarterly basis in support of Management reviews and KPIs
Assist with various quality risk management frameworks, including Annual Product Quality Report preparation
Support cGMP compliance audits of internal and GMP suppliers’ quality systems
Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
Perform other related duties as assigned from time to time-based on company needs