QA Specialist I

Ardelyx, Inc. in Fremont, CA

  • Type: Full Time
position filled


Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx’s cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.

QA Specialist I-III (CSV)

Purpose of the role:

This role will be responsible for QA oversight of all GxP Computer Systems Validation. The incumbent, working with the functional teams must ensure that all GxP regulated systems are purchased, audited, installed and maintained based on industry best practices (e.g. GAMP5) and regulatory requirements (e.g. 21CFR Part 11 and relevant FDA Guidance). The position plans and organizes all QA activities for computer system validation projects. Duties include, but are not limited to, oversight and approval of validation - related documents, leading risk assessments and working with project team to determine which elements should be validated, conducting and/or coordinating impact assessments of proposed changes to computerized systems and leading inspection (external/internal) readiness activities related to computer system validation. The candidate will ensure that all GxP computer systems are maintained in a validated state in addition to designing work processes for users and administrators of the aforementioned systems.

This position will interact with regulatory agencies and corporate partners during inspections and audits, and will require travel for auditing computerized system vendors off -site. The incumbent will develop and execute strategies to ensure CSV compliance and consistent application of these policies/processes.

Position Responsibilities:

  • Provide quality oversight for the implementation/validation efforts, with input from project team, of any GxP computer systems
  • Review and approve validation deliverables of new computer systems as required including validation plans, requirement specification documents, validation protocols, test scripts, validation reports and trace matrices
  • Responsible for maintenance of validated state of all GxP computer systems including re-validation, management of change controls, periodic review, and lifecycle management
  • Responsible for the management of the GxP Computer System Inventory List
  • Ensure that the control of GxP computer systems is integrated into Quality Management System
  • Provide quality oversight for the migration of GxP data/records
  • Write and implement policies and supporting SOP s, Work Instructions/Forms and training materials to cover Ardelyx regulated computer systems
  • Ensure that vendor assessments, audits and quality agreements (if required) of suppliers of GxP computer software are in place
  • Plan, organize, and manage the activities of external CSV contractors and/or consultants
  • Represent QA CSV and participate in multi-departmental project team meetings including assisting IT department with integration of other software
  • Train employees on processes and workflows associated with GxP computer systems, including inspection requirements, and promote technical development
  • Perform other related duties as assigned from time to time based on company needs
  • Position Requirements:

  • BS in a technical discipline, science /engineering discipline preferred but not required equivalent experience may be considered
  • 1-7 years’ experience in a Quality environment CSV, with exhibited knowledge and proficiency of requirements for implementing, validating, and maintaining GxP computer systems in the Life Science Industry
  • Practical understanding of CFR Title 21 (Parts 11, 210, and 211), GAMP5, Annex 11, electronic record/electronic signature, and data integrity requirements, standards and guidelines
  • Understanding and familiarity with FDA regulatory requirements, guidelines, and recommendations for computerized system lifecycle management
  • Ability to comprehend technical information related to computer software (operating systems, software applications), computer and network hardware, and the associated regulatory expectations relating to them
  • Ability to manage CSV contractors and auditors if needed
  • Experience in other Quality roles is a plus
  • Excellent leadership, technical, management, problem solving and project management skills
  • Organizational and management skills to handle multiple functional groups and influence others.
  • Ability to speak, present data, and defend approaches in front of audiences and inspectors
  • Experience and proficiency with industry standard enterprise system applications (QMS, LMS, MES, EDMS, ERP, CMMS)

  • As a member of the Ardelyx team, you will help us in developing and bringing to market first in class medicines to better the lives of underserved patients with cardiorenal diseases. 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 seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture and research environment.

    Ardelyx, Inc. is an Equal Opportunity Employer.

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