Quality Assurance Systems Specialist III

Menlo Park, CA 94025

Posted: 09/03/2019 Employment Type: Direct Hire Industry: Clinical & Scientific Job Number: 16367

Job Description

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.


Specific Skills/Abilities
  • 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.


Meet Your Recruiter

Jesse Ashworth

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