Quality Assurance


Fremont, CA, US
  • Job Type: Full-Time
  • Function: Engineering QA
  • Post Date: 04/28/2021
  • Website: ardelyx.com
  • Company Address: 34175 Ardenwood Blvd., Fremont, CA, 94555

About Ardelyx

Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines.

Job Description

Ardelyx is a publicly traded biotech company focused on improving the lives of patients by developing and commercializing first-in-class targeted therapies that advance patient care. Using our discovery model, Ardelyx scientists have characterized new biological mechanisms and pathways that have enabled us to develop a pipeline of drug candidates to manage complications related to kidney and cardiovascular diseases. Our lead candidate, tenapanor, is a first-in-class small molecule therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease on dialysis. If approved, tenapanor could completely change the treatment paradigm in a disease state with significant unmet need.  We are advancing the build of our commercial organization to be prepared for launch of tenapanor in mid-2021.

Purpose of the role

The QA Specialist I-III will provide QA support for Quality Operations and Quality System management. 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 perform batch records review, data review and product dispositions, to implement sound Quality System improvements and manage QA procedures, assess GMP suppliers and service providers, and perform QA oversight of contract manufacturers. In addition, the position requires someone with strong document management and change control experience in procedures, specifications, and storage requirements used in GMP environment.


Position Responsibilities

  • Perform batch related records review and product dispositions in support of clinical trials, products registration, and commercial sales and marketing
  • Evaluate compliance of completed manufacturing records (batch records, forms, etc.) and quality control records (test/analytical results)
  • Review and approve COC and COA (including associated raw data from CMO) to ensure that they are accurate and complete
  • Participate in the review of analytical methods, method validation protocols and reports including revisions and associated change controls
  • Participate in the review of specifications, including justifications for specifications and subsequent revisions and associated change controls
  • Evaluate and manage change controls for compliance requirements (e.g., Master Batch records, specifications, test methods, etc.)
  • Liaise with Regulatory Affairs on any manufacturing process/method/specification changes that may impact regulatory filings
  • Review all the supporting documents regarding Quality System documentation including deviations (such as OOS), CAPAs, and change controls
  • Review stability protocol per internal procedure, ICH or post approval commitment requirements
  • Review and approve stability data generated internally or externally (including identification of trend)
  • Support QA CMO oversight activities to ensure required quality standards are maintained
  • Collaborate with Manufacturing and Analytical Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve minor and major deviations
  • Support the analysis and reporting of product and process quality trends, and quality system performance against internal and external guidelines, standards and regulations
  • Quality audit of regulatory submissions
  • Support cGMP compliance audits of GMP suppliers’ quality systems
  • Support Document Control related processes
  • Support and conduct training for employees, as necessary
  • Perform other related duties as assigned from time to time based on company needs


Position Requirements

  • Bachelors’ or higher degree in sciences
  • 7+ years of combined manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in a biotechnology or pharmaceutical industries
  • 5+ years’ experience in a GMP environment
  • Some experience in manufacturing of drug substances or drug products a plus
  • 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 under tight deadlines and pressure in a composed manner
  • Effective interpersonal and communication skills
  • Strong team player
  • Comfortable communicating with all levels of staff, including executives

As a member of the Ardelyx team, you will play a key role in developing and bringing to market first-in-class medicines to better the lives of underserved patients.  It’s the patients in need that motivate and inspire us to be relentless and work hard every day. They push us to maintain a clear focus on scientific and clinical integrity with a commitment to medical innovation so that we can deliver exceptional medicines.  We are different for good.

Ardelyx, Inc. is an Equal Opportunity Employer

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Disclaimer: Local Candidates Only
This company does NOT accept candidates from outside recruiting firms. Agency contacts are not welcome.