Quality Assurance Specialist - III/IV

2 days ago

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Ardelyx, Inc.

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Description

•Provide QA support for Quality Operations •Support the reporting of Quality metrics •Support various quality risk management frameworks •Perform batch record review and product dispositions •Evaluate compliance of completed manufacturing records •Maintain Continued Process Verification data collection •Review supporting documents regarding Quality System documentation •Evaluate document changes for compliance requirements •Support analysis and reporting of quality trends •Support QA CMO oversight activities •Liaise with Regulatory Affairs on manufacturing process changes •Collaborate with CMC to improve compliance •Support Product complaint-handling activities •Support Annual Product Quality Report preparation •Support cGMP compliance audits •Support and conduct training for employees •Perform other related duties as assigned

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, analytical development, and/or quality control experience in biotechnology or pharmaceutical industries •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 US, EU, and ICH) •Extensive experience with Quality Assurance systems and processes •Effective organization and planning skills •Demonstrated ability to deal with frequent changes, delays, or unexpected events •Strong technical writing skills •Advanced software skills (including SharePoint, Visio, Project, Acrobat Pro, and Veeva (a plus)) and demonstrated troubleshooting and problem-solving techniques •Strategic planning, leadership, and negotiation skills, and the ability to develop and present training materials to large groups •Proven ability to work independently and under tight deadlines and pressure in a composed manner •Effective interpersonal and communication skills •Comfortable communicating with all levels of staff, including executives •Strong team player

Benefits

•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 shut down •at least 11 paid holidays