QA Specialist

Quality Assurance Specialist III, AnalyticalArdelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. The Quality Assurance Specialist III, Analytical is responsible for the review and approval of analytical quality documentation supporting commercial and clinical products, including intermediates, drug substances (APIs), and drug products manufactured and tested by Ardelyx contract manufacturing organizations (CMOs) and contract laboratories. The role supports quality oversight of laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), and other atypical analytical results, while ensuring compliance with applicable GMP regulations and internal procedures. The position also contributes to continuous improvement initiatives that enhance the effectiveness and compliance of Ardelyx's Quality System. A strong background in small molecule analytical methodologies (e.g., wet chemistry, HPLC/UPLC, GC, dissolution, and other compendial techniques) is essential to support the review of in-process, release, validation, and stability analytical documentation. The successful candidate will collaborate effectively with CMOs, contract laboratories, Regulatory Affairs, Manufacturing, Technical Operations, and cross-functional stakeholders to support timely product disposition, laboratory investigations, and regulatory compliance.This is a hybrid-based role working 2-3 days per week out of our Newark, CA office.Responsibilities:Review and approve analytical quality documentation supporting regulatory submissions (e.g., INDs, NDAs, amendments, supplements, and annual reports), ensuring compliance with applicable regulatory requirementsReview and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batchesEvaluate completed analytical records (raw data, laboratory notebooks, reports, CoAs, CoTs, and supporting documentation) to ensure accuracy, completeness, and compliance with GMP requirementsReview analytical methods, method validation protocols and reports, method transfers, and associated change controlsParticipate in the review of specifications, specification justifications, and specification revisionsReview document changes (e.g., SOPs, specifications, analytical methods, master batch records) for GMP complianceSupport Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes that may impact regulatory submissionsReview Quality System records, including deviations (OOS, OOT, laboratory investigations), CAPAs, change controls, and risk assessments, ensuring timely completion and complianceReview and approve stability protocols, reports, and stability data in accordance with internal procedures and applicable regulatory requirementsReview stability data generated internally or externally, including trend evaluationCollaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality-related issuesParticipate in continuous improvement initiatives to enhance analytical quality processes and quality system effectivenessQualifications:Bachelor's degree in Chemistry, Pharmaceutical Sciences, Biology, or a related field with 5+ years of experience in analytical development, manufacturing, or quality assurance within the biotechnology industry or equivalent experience3+ years of experience in a GMP environmentExperience supporting regulatory submissions (e.g., INDs, NDAs, amendments, and supplements) preferredExperience working with CMOs and contract laboratories preferredExperience using electronic Quality Management Systems (e.g., Veeva Vault, TrackWise) preferredExperience reviewing analytical methods, method validation, method transfer, change controls, and stability documentationWorking knowledge of applicable GMP regulations and guidance, including FDA, ICH, USP/NF, and other pharmacopeial standardsExperience with drug substance and drug product analytical testing, including troubleshooting and problem-solvingStrong written and verbal communication skills with internal and external stakeholdersEffective organizational, planning, and time-management skillsAbility to manage multiple priorities in a fast-paced environmentDemonstrated attention to detail and sound decision-making skillsProficiency with Microsoft 365 applications, SharePoint, and VeevaThe anticipated annualized base pay range for this full-time position is $105,000-$129,000. 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 of 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. We do not accept unsolicited resumes from search firms, or recruiters or similar vendors. Any such unsolicited resume submitted to any employee or through Company's career site without a valid, signed search agreement signed by Company's authorized representative will be deemed the property of the company, and no fees will be paid in the event of a hire. Company will have the right to hire any such candidate at its discretion without any financial obligation or fee owed to the vendor. Any verbal or written communication with a Company employee outside of this process will not be considered a binding agreement.