Documentation Specialist – Biotechnology

Have experience documenting SOPs for enterprise IT systems in a Life Sciences R&D environment?

If you have experience documenting systems and process documentation, including SLC, CSV, change controls, SOPs, design specifications, and work instructions, we want to hear from you. SQA is looking for a Documentation Specialist to work with a biotechnology client seeking New Drug Application (NDA) approval.

In this fast-paced environment, the ideal candidate will be self-directed within the framework of IT and corporate policies. If you thrive in small company environments, this is an opportunity to help implement IT systems in support of business initiatives.

Required experience and responsibilities include:

  • Developing SOPs for an enterprise software system, including SLC, CSV, change controls, design specs and work instructions
  • Creating training documentation and user guides for a customized software system implementation
  • Working with technical writing tools
  • Excellent written and verbal communication skills
  • Strong understanding of GxP and regulations, including 21CFR Part 11

Job ID: 1809-5629
SQA is an equal opportunity employer and supports workforce diversity.