QA Specialist III - Analytical (Small Molecule)
Ardelyx, Inc.
August 15, 2026
Remote friendly (Newark, CA)
United States
Operations
Responsibilities:
- Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports).
- Review and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batches.
- Evaluate analytical records (raw data, lab notebooks, reports, CoAs/CoTs, supporting documentation) for accuracy, completeness, and GMP compliance.
- Review analytical methods, method validation protocols/reports, method transfers, and associated change controls.
- Review specifications, specification justifications, and specification revisions.
- Review document changes (SOPs, specifications, analytical methods, master batch records) for GMP compliance.
- Support Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes impacting submissions.
- Review Quality System records (deviations/OOS/OOT, lab investigations, CAPAs, change controls, risk assessments) for timely completion and compliance.
- Review and approve stability protocols/reports and stability data; evaluate internal/external stability trend data.
- Collaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality issues.
- Participate in continuous improvement initiatives to enhance analytical quality processes and the Quality System.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, Biology, or related field + 5+ years in analytical development, manufacturing, or QA in biotechnology (or equivalent).
- 3+ years experience in a GMP environment.
- Preferred: regulatory submission experience (INDs/NDAs/amendments/supplements), CMO/contract laboratory experience, and use of eQMS (Veeva Vault, TrackWise).
- Experience reviewing analytical methods/validation/transfer, change controls, and stability documentation.
- Working knowledge of GMP regulations/guidance (FDA, ICH, USP/NF).
- Experience with drug substance and drug product analytical testing, including troubleshooting.
- Strong written/verbal communication; organizational/time-management; manage multiple priorities; attention to detail and sound judgment.
- Proficiency with Microsoft 365, SharePoint, and Veeva.
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays.
Application instructions:
- Hybrid role: work 2–3 days per week from Newark, CA office.
- Review and approve analytical quality documentation supporting regulatory submissions (INDs, NDAs, amendments, supplements, annual reports).
- Review and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batches.
- Evaluate analytical records (raw data, lab notebooks, reports, CoAs/CoTs, supporting documentation) for accuracy, completeness, and GMP compliance.
- Review analytical methods, method validation protocols/reports, method transfers, and associated change controls.
- Review specifications, specification justifications, and specification revisions.
- Review document changes (SOPs, specifications, analytical methods, master batch records) for GMP compliance.
- Support Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes impacting submissions.
- Review Quality System records (deviations/OOS/OOT, lab investigations, CAPAs, change controls, risk assessments) for timely completion and compliance.
- Review and approve stability protocols/reports and stability data; evaluate internal/external stability trend data.
- Collaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality issues.
- Participate in continuous improvement initiatives to enhance analytical quality processes and the Quality System.
Qualifications:
- BS in Chemistry, Pharmaceutical Sciences, Biology, or related field + 5+ years in analytical development, manufacturing, or QA in biotechnology (or equivalent).
- 3+ years experience in a GMP environment.
- Preferred: regulatory submission experience (INDs/NDAs/amendments/supplements), CMO/contract laboratory experience, and use of eQMS (Veeva Vault, TrackWise).
- Experience reviewing analytical methods/validation/transfer, change controls, and stability documentation.
- Working knowledge of GMP regulations/guidance (FDA, ICH, USP/NF).
- Experience with drug substance and drug product analytical testing, including troubleshooting.
- Strong written/verbal communication; organizational/time-management; manage multiple priorities; attention to detail and sound judgment.
- Proficiency with Microsoft 365, SharePoint, and Veeva.
Benefits:
- 401(k) with generous employer match; 12 weeks paid parental leave; up to 12 weeks living organ and bone marrow leave; health plans; life insurance and disability; flexible time off; annual Winter Holiday shutdown; at least 11 paid holidays.
Application instructions:
- Hybrid role: work 2–3 days per week from Newark, CA office.