Quality Assurance Specialist II-III - Fremont - Ardelyx

    Ardelyx
    Ardelyx Fremont

    16 hours ago

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    Description

    Ardelyx is a publicly traded commercial biopharmaceutical company with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. The company has two commercial products approved in the United States: IBSRELA (tenapanor) and XPHOZAH (tenapanor). For tenapanor outside of the U.S., Ardelyx has agreements for development and commercialization.

    Purpose of the role

    QA Specialist II-III Responsibilities:

    • Perform batch-related records review and product dispositions in support of clinical trials, product registration, and commercial release and stability.
    • Evaluate compliance of completed analytical records (raw data capture, forms, reports, CoA, CoT, etc.) to ensure accuracy and completeness.
    • 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 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:

    • Bachelor's degree or higher in sciences.
    • 3-7+ years of combined manufacturing process development, commercial manufacturing, analytical development, and/or quality control experience in a biotechnology or pharmaceutical industry.
    • 3-5+ 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 ensure timely completion of tasks.
    • 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).

    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 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 shutdown, and at least 11 paid holidays.

    Ardelyx is an equal opportunity employer.

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