QA Specialist III - Analytical (Small Molecule)

Ardelyx 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 requirements 
• Review and approve batch-related analytical documentation and support product disposition for clinical, registration, commercial, and stability batches 
• Evaluate completed analytical records (raw data, laboratory notebooks, reports, CoAs, CoTs, and supporting documentation) to ensure accuracy, completeness, and compliance with GMP requirements 
• Review analytical methods, method validation protocols and reports, method transfers, and associated change controls 
• Participate in the review of specifications, specification justifications, and specification revisions 
• Review document changes (e.g., SOPs, specifications, analytical methods, master batch records) for GMP compliance 

• Support Regulatory Affairs by reviewing manufacturing process, analytical method, and specification changes that may impact regulatory submissions

• Review Quality System records, including deviations (OOS, OOT, laboratory investigations), CAPAs, change controls, and risk assessments, ensuring timely completion and compliance 
• Review and approve stability protocols, reports, and stability data in accordance with internal procedures and applicable regulatory requirements 
• Review stability data generated internally or externally, including trend evaluation 
• Collaborate with CMOs, contract laboratories, Manufacturing, Analytical Development, and Technical Operations to resolve quality-related issues 
• Participate in continuous improvement initiatives to enhance analytical quality processes and quality system effectiveness

Qualifications:

• 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 experience
• 3+ years of experience in a GMP environment
• Experience supporting regulatory submissions (e.g., INDs, NDAs, amendments, and supplements) preferred
• Experience working with CMOs and contract laboratories preferred
• Experience using electronic Quality Management Systems (e.g., Veeva Vault, TrackWise) preferred
• Experience reviewing analytical methods, method validation, method transfer, change controls, and stability documentation
• Working knowledge of applicable GMP regulations and guidance, including FDA, ICH, USP/NF, and other pharmacopeial standards
• Experience with drug substance and drug product analytical testing, including troubleshooting and problem-solving
• Strong written and verbal communication skills with internal and external stakeholders
• Effective organizational, planning, and time-management skills
• Ability to manage multiple priorities in a fast-paced environment
• Demonstrated attention to detail and sound decision-making skills
• Proficiency with Microsoft 365 applications, SharePoint, and Veeva