Ardelyx® is building an integrated biopharmaceutical company with a gastrointestinal and cardio-renal focus. Our mission is to serve patients through the discovery, development and commercialization of minimally-systemic therapeutics that target intestinal receptors and transporters to address unmet medical needs.
Seeking a Quality Assurance Specialist to provide QA support for Quality Operations and Quality System management. 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 Analytical activities.
The position requires diverse skill sets and will provide the opportunity to challenge an individual’s abilities to perform batch records review and product dispositions, to implement sound Quality System improvements and manage QA procedures, assess GMP suppliers and service providers. In addition, the position requires someone with strong skills in document management and change control procedures and deviations and CAPA processes in a GMP, GCP and GLP regulated environment.
- Work with CMOs and internal stakeholders in the quality review and approval of analytical methods, method validation protocols and reports including revisions and associated change controls
- Work with CMOs and internal stakeholder in the quality review and approval of specifications, including justifications for specifications and subsequent revisions to specifications
- Liaise with Regulatory Affairs on any method/specification changes that may impact regulatory filings
- Manage, evaluate and approve Quality System documentation including deviations (such as OOS), CAPAs, and change controls
- Review and approve stability protocols per internal procedure, ICH or post approval commitment requirements
- Review and approve stability data generated internally or externally (including identification of trend)
- Review and approve SOPs, Manufacturing records, forms, quality control records, and documents related to analytical activities
- Perform QA CMO oversight activities to ensure requiredquality standards are maintained
- Collaborate with Manufacturing and Analytical Development to continually improve compliance with quality systems, internal SOPs and regulatory requirements and to resolve minor and major deviations
- Participate in cGMP compliance audits of GxP suppliers’ quality systems
- Support Document Control related processes
- Support and conduct training for employees, as necessary
- Analyze and report product and process quality trends, and quality system performance against internal and external guidelines, standards and regulations
- Prepare trend reports related to manufacturing process performances, deviations, test method performances and laboratory deviations.
- Follow up with functional department for timely completion of corrective/preventive actions and recommendations
- May serve as the quality operational technical representative on project teams evaluating new documentation processes or systems
- Perform other related duties as assigned from time to time based on company needs
- Bachelors’ or higher degree in sciences
- 10+ years of analytical experience in a biotechnology or pharmaceutical industries (Method development, method validation/verification, method transfer, data review and approval, OOS investigation, protocol design)
- 5+ years’ experience in a GMP environment
- Some experience in manufacturing of drug substances or drug products a plus
- 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 under tight deadlines and pressure in a composed manner
- Effective interpersonal and communication skills
- Strong team player
- Comfortable communicating with all levels of staff, including executives
As a member of the Ardelyx team, you will help develop therapeutics that are designed to act in the gastrointestinal tract with minimal systemic exposure. Our drug candidates target important diseases and conditions. We are developing novel therapeutic agents that address unmet medical needs, with a gastrointestinal and cardio-renal focus.
We are seeking the best in class scientists, advanced thinkers, and people who thrive on collaboration to co-create the future. You will be working with some of the industry's best scientists in a team environment focused on world class research. Ardelyx offers a competitive total rewards package, perks and an innovative and dynamic culture.
Ardelyx, Inc. is an Equal Opportunity Employer.