Quality Assurance Systems Specialist
Oakland-Fremont-Pleasanton Metro Area, CA
Key Accountabilities/Core Job Responsibilities:
Track quality metrics for Quality Management System processes, analyze data and coordinate quality continuous improvement activities.
Support risk management-based approaches.
Review and track deviations and investigations related to material disposition.
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 manufacturing documents for clinical products in compliance with US and international health agency requirements as needed.
Coordinate, lead and conduct internal investigations as well as investigations at contract service providers as needed.
Advocate and maintain quality systems and policies throughout the company.
Assist in additional quality functions as needed.
Education and Training:
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 electronic systems is a plus.
Experience 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.