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Technical Writer/Investigator (Home Based)

NES Fircroft

This is a Full-time position in Atlanta, GA posted March 24, 2021.

A bio-pharmaceutical client in the Bay Area is looking to add a contract Technical Writer / Investigator to their Quality te am for the next 6 months. Ideal candidates will come from a strong technical writing background and will have the ability to 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 & Quality Systems and will focus on developing our clients policies, data, operational structure, and products, while helping to identify new ways to enhance GxP compliance through the application of Quality Systems.

Additionally, you will work with the SME’s to prepare new documents/changes to existing Policies, SOPs, and Work Instructions, while helping to establish electronic systems for Investigations and Change Control. Ideal candidates will focus on compliance, driving results, and upstream thinking with the ability to ability to manage multiple simultaneous projects and stick to project deadlines.

Job Requirements:

Must have:

  • Bachelor’s degree in a scientific-related field or equivalent experience and 8-10 years of experience in the life sciences industry
  • Prior experience working management teams to determine revisions on quality procedures and standards – must have prior experience creating and translating process maps to apply to SOP writing.
  • 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.
  • Lean / Six Sigma experience is a plus
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