Quality Assurance Specialist II-III (Analytical)

Quality Assurance Fremont, California

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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.    

Purpose of the role
 
The QA Specialist II-III will be responsible for analytical data review/verification supporting both commercial and clinical assets, including intermediate/API/drug products provided by Ardelyx CMOs and contract laboratories. The position will also be responsible for oversight of investigations of unexpected events (e.g. OOS, OOT and anomalous results).  The position will also be expected to be engaged in continuous improvement initiatives to drive efficiency and effectiveness of Ardelyx’s Quality Systems.
 
A strong background in small molecule analytical methods (e.g. wet chemistry, GC, HPLC/UPLC, dissolution) will be essential to perform the review of batch-related analytics including IPC, release and stability documentation. A demonstrated ability to communicate/collaborate with external service providers and internal stake holders to drive timely release of batch related analytics, laboratory investigations, and project related improvements is required. 
 
Position Responsibilities 
  • Perform batch related records review and product dispositions in support of clinical trials, products registration, and commercial release and stability
  • Evaluate compliance of completed analytical records (raw data capture, forms, reports, CoA, CoT, etc.) to assure the documents 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 to specifications
  • Evaluate document changes for compliance requirements (SOPs, 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
  • 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
  • 3 to 7+ years of combined manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in a biotechnology or pharmaceutical industries
  • 3 to 5+ years’ experience in a GMP environment
  • Experience in analysis of both drug substance and drug product with demonstrated troubleshooting and problem-solving techniques
  • Extensive knowledge of GMP regulations and guidance (such as ICH, USP/NF, JP)
  • Proven ability to work under tight deadlines and pressure in a composed manner
  • Demonstrated ability to deal with frequent changes, delays or unexpected events
  • Communication (verbal and written) and negotiation skills in working with contract service providers to assure timely completion of task
  • Comfortable communicating with all levels of staff, including executives
  • Effective organization and planning skills
  • Working knowledge of Quality Assurance systems and processes
  • Standard software skills (including MSo360 products, SharePoint, Box and Veeva)
Location
  • Hybrid to Fremont, CA.
The anticipated annualized base pay range for this full-time position is $91,217- $101,352.  Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers.  Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity.  The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.     
 
Ardelyx also offers a robust benefits package to employees, including a 401(k) plan with generous employer match, 12 weeks of paid parental leave, up to 12 weeks living organ and bone marrow leave, equity incentive plans, health plans (medical, prescription drug, dental, and vision), life insurance and disability, flexible time off, annual Winter Holiday shut down, and at least 11 paid holidays. 
  
Ardelyx is an equal opportunity employer.   

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