Contract - Technical Writer/Investigator

San Francisco, CA, United States
Oct 16, 2020
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time

Position Summary:

The Technical Writer / Investigator is a highly-skilled individual with life science industry experience. Technical writers communicate complex information clearly, concisely and accurately, without relying on jargon. In this role, you will serve as a liaison working with Quality and Operations to drive strategic compliance priorities in support of Quality Management. This role reports to the Director of Business Operations and Quality Systems.

Essential Duties and Responsibilities:
  • Develop a deep understanding of the company's policies, data, operational structure, and products to identify ways to enhance GxP compliance through the application of Quality Systems
  • Work with Subject Matter Experts to prepare new documents or changes to existing Policies, SOPs, and Work Instructions
  • Aid in establishing electronic systems for Investigations and Change Control.
  • Calibrates with the business and management to determine revisions on quality procedures and standards
  • Creates and Translates process maps or other business representations to apply to SOP writing
  • Maintain ongoing awareness of industry and organization-wide best practices for quality and share information across the board as necessary
  • Support efforts to understand requirements, for any new regulations, conduct gap analyses of system, processes, and supporting documentation, outline impact, define changes required, and support implementation to verify compliance
  • Regularly analyze and report trends to support QMRs. Highlight opportunities to drive improvements in Quality across all functions
  • Collaborate with internal teams to develop training, onboarding, content and focused coaching based on industry trends

  • Bachelor's degree in a scientific-related field or equivalent experience and 8-10 years' experience in the life sciences industry
  • High level of professionalism and collaboration in team settings
  • Focus on compliance, driving results, and upstream thinking.
  • Ability to quickly ramp up knowledge of business and quality management systems
  • Fluency with MS office products, in particular, MS Word
  • Organized, detail-oriented, able to perform tasks methodically, and can employ critical thinking in problem-solving
  • Ability to manage multiple simultaneous projects with attention to detail and delivery dates.
  • Able to escalate risk with the necessary urgency.
  • Strong interpersonal skills with the ability to clearly communicate in writing and verbally.
  • Lean / Six Sigma experience is a plus