QA Specialist III

Ardelyx • Newark, CA

2d • $113,000 - $129,000 • Hybrid

About The Position

The QA Specialist III / IV will provide QA support for Quality Operations. Working in a fast-paced pharmaceutical environment with a broad scope of responsibilities, the candidate will be able to bring many different skills to the job, with a focus on QA activities. The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to carry out the assigned responsibilities. In addition, the position requires the candidate to possess strong document and quality risk assessment management experience, in a GxP environment. This will be a hybrid position based out of the Newark, CA office.

Requirements

• Bachelor’s degree in science or equivalent relevant experience
• 7+ years of combined GxP experience in drug substance and drug product manufacturing process development, commercial manufacturing, packaging, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries
• Experience in relevant CMC area (DS, DP) , with an ability to introduce Quality-relevant (phase appropriate) best practices into the CMC development processes.
• Experience in a manufacturing setting as a Quality person in the plant (QA PIP)
• Working knowledge and/or understanding of quality risk assessment management principles
• Extensive knowledge of GMP regulations and guidance (such as FDA, EU, and ICH)
• Extensive experience with Quality Assurance systems and processes
• Excellent investigational and QA problem-solving skills
• Demonstrate ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills
• Advanced software skills (including SharePoint, and Veeva (a plus))
• Proven ability to work independently and under tight deadlines and pressure in a composed manner
• Effective interpersonal and communication skills, and teamwork oriented
• Comfortable communicating with all levels of staff, including executives

Responsibilities

• Perform batch record review and product disposition in support of clinical trials, registration, validation, and commercial product distribution
• Evaluate compliance of completed manufacturing records (batch records, COC/ COA, packaging, and any related data as applicable) from CMO as necessary to ensure accuracy and completeness
• Collaborate with CMC to conduct compound/product specific risk assessments, as required, for all aspects of the drug development process
• Review development, and validation protocols and reports
• Participate in ensuring compliance with quality systems, internal SOPs, deviations, OOS, product complaints, CAPAs, change controls-related processes and regulatory requirements
• Support QA CMO oversight activities to ensure required quality standards are maintained
• Support the reporting of Quality metrics on a monthly, and quarterly basis in support of Management reviews and KPI
• Support various quality risk management frameworks
• Support the Annual Product Quality Report preparation
• Support cGMP compliance audits of internal and GMP suppliers’ quality systems
• Liaise with Regulatory Affairs on any manufacturing process changes that may impact regulatory filings
• Perform other related duties as assigned from time to time-based on company needs

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level