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QA Systems Specialist III (Master Control System Administrator)

Company: Adverum Biotechnologies
Location: Redwood City
Posted on: June 4, 2021

Job Description:

Our Quality Assurance team is looking to bring onboard a Quality Systems Specialist III. This individual will perform and maintain Quality Assurance (QA) programs, systems, policies, processes, procedures and controls as they relate to the manufacture, analytical testing, and disposition of clinical materials manufactured at Contract Service Providers. What you'll do:Project lead for MasterControl validated quality systems software.Support a successful implementation of MasterControl.Communicate, Collaborate with Mastercontrol any challenges encountered during implementation of the quality systems.Accountable for the MasterControl end users training of all quality systems. Lead the User Acceptance Testing of quality systems and communicate challenges to MastercontrolTrack quality metrics for Quality Management System processes, analyze data and coordinate quality continuous improvement activities. Support risk management-based approaches. Represent QA on cross-functional teams to complete projects, address quality issues and identify quality system improvements. Develop or review quality processes supporting change management and ensuring compliance with current Good Manufacturing Practice (cGMP) requirements. Assist in the review and approval of documents for clinical products in compliance with US and international health agency requirements as needed. Advocate and maintain quality systems and policies throughout the company. Assist in additional quality functions as needed.About you:BA/BS degree in Biological Sciences, Chemistry, or related field and/or equivalent experience.Minimum 7 years of Pharma/Biotech industry experience in Quality Assurance (QA) in a GxP environment, preferably in an advanced therapy such as gene therapy. Detail-oriented with a QA background. Ability to work effectively in a team environment with exceptional organizational skills. Direct experience with key quality systems (e.g., Change Management, Vendor Management, Deviations/CAPA, and Management Review); experience with validated electronic systems. Experience in developing and reporting quality metrics. Excellent working knowledge and understanding of GxP requirements, proficiency in applying regional regulatory and ICH guidelines. Broad experience in the bio-pharmaceutical industry with a strong analytical and/or manufacturing background, some R & D experience a plus. Excellent working knowledge of quality systems and GxP standards applicable to product life cycle from development to commercial. Ability to prioritize and coordinate with other functions in order to meet deadlines efficiently. Ability to provide internal training with excellent public speaking skills. A self-starting, highly motivated individual with strong interpersonal and communications skills, both verbal and written, to provide clear direction for internal stakeholders and vendors. Proven initiative and demonstrated accountability in a fast-paced environment with high degree of flexibility. Proficient with the Microsoft Office software, including Word, Excel, PowerPoint. Experience with Project a plus. Possess positive attitude, with good organizational skillsAbility to work in a fast pace environmentAbility to work independently with minimal instruction About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation Associated topics: qa, quality, quality assurance, quality assurance analyst, quality assurance engineer, quality assurance lead, software quality assurance, software quality assurance engineer, test, tester

Keywords: Adverum Biotechnologies, Redwood City , QA Systems Specialist III (Master Control System Administrator), Other , Redwood City, California

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