Quality Assurance Systems Specialist III
1035 O'Brien Drive Menlo Park, CA 94025
Senior Systems Specialist Quality Assurance
Menlo Park CA / Redwood City, CA (in early 2020)
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.