Contract Computer Systems Analyst

Location
San Francisco, CA
Posted
Nov 02, 2018
Ref
369
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
CONTRACT COMPUTER SYSTEMS ANALYST

Essential Duties and Responsibilities:

  • Author, review and approve validation documents, ensuring regulatory requirements and quality standards
  • Initiate and assist with GxP and Risk Assessments reports
  • Author, Initiate, and/or review and approve SOPs related to compliance
  • Collaborate with project stakeholders to define requirements
  • Provide support to executors of the protocols when needed
  • Write reports summarizing system validation activities

Qualifications:
  • BS degree in Computer Science, IT, Biomedical, Pharmaceutical, Chemical or any other variety of engineering with years of experience in Information Technology and computer system Compliance and/or Validation
  • 3+ years' experience in FDA regulated environment with strong understanding of cGxP standards and Risk based validation
  • Knowledge of FDA guidance and industry standards (i.e., Quality Systems, GAMP, 21CFRPart11)
  • Experience in developing or reviewing system Validation Plans, Requirements, Design Specifications, Test Protocols, Deviation management, Traceability matrices and Validation Summary Reports
  • Strong verbal and written communication skills