Senior Associate, Quality Assurance - Innovative Gene Therapy

Location
Menlo Park, California
Posted
Apr 04, 2018
Required Education
Bachelors Degree
Position Type
Full time

RESPONSIBILITIES

  • Ensures support with compliance and ongoing preparation for new projects
  • Knowledge of vendor qualification and management
  • Assist with internal training on QA Policies and Procedures
  • Maintains equipment history files
  • Establishes and maintains personnel training records and ensures training is current
  • Assist in the generation and review of documents used in Manufacturing and Quality Control Testing for accuracy and completeness
  • Prepares documentation for filing and maintains original documents and computerized files to support all documentation systems
  • Ensures that records are secure, and retrievable throughout defined record retention periods
  • Assigns deviation report numbers and maintain all approved reports

EXPERIENCE & SKILLS

The ideal candidate should have:

  • Directly relevant experience with biologics or biotechnology derived products
  • Ability to work independently and in a group on a variety of projects
  • Ability to maintain a high degree of accuracy and attention to detail
  • Ability to handle a fast-paced, multi-tasking environment, and prioritize effectively
  • Planning, organization and execution skills
  • Strong problem-solving techniques and ability to make sound decisions
  • Capable of assisting with analysis of trends and metrics that lead to improvement
  • Must be able to multi-task and establish priorities
  • Must work well with others and possess effective teaching abilities
  • A thorough knowledge and understanding of Canadian, US FDA and European regulations (GMP), as well as experience with GLPs.
  • Competency with electronic Quality Management Systems
  • Proficiency in Microsoft Office (Word, Excel, Outlook, etc.)
  • Excellent verbal and written communication skills required
  • Strong presentation and negotiation skills required

EDUCATION

  • A Bachelor’s in Chemistry, Biochemistry, Biology, Pharmacy, or in a related discipline.
  • A minimum of three (3) years knowledge and working experience with all aspects of quality assurance, which relate to a pharmaceutical development organization.