Career Category

Quality

Job Description

QA Specialist- Document Management System (DMS) Tech Writing & Operations Support

Let’s do this. Let’s change the world

Roles & responsibilities:

As integral part of the DMS technical writing team member working globally with Quality operations activities and other requirements:

• Provide technical writing and editing expertise to support the generation of robust, well-written Quality operations-controlled documents.
• Support optimization and maintenance of the DMS process, including updates to the procedure, the system (CDOCS), and associated training materials
• Maintain and enhance DMS document templates and authoring standards to ensure consistency and compliance
• Lead technical writing tasks in support of process and document simplification efforts.
• Execute standard and streamlined document creation/revision process following a hierarchy structure and templates per procedures and approved protocol
• Responsible to redline document, manage review workflow, assess comments, complete edits, submit for approval, report progress, confirm due date is met. Create, update, and deliver training materials for document owners, reviewers, and approvers on good Quality writing per our document hierarchy and document authoring standards
• Update, optimize, and maintain the CDOCS support portal (Share Point) – including training links, e Learnings, Quick Reference Guides, and other related materials
• Support of Document Management Network – maintenance of meetings, Teams channel, inspection readiness materials, etc.
• Provide additional operational support for DMS activities as needed.
• Due to the global nature of the role, must be willing to work a shift that overlaps with EU and US time zones long term (ex. coverage of 9 - 12 EST at a minimum within the shift).

Basic Qualifications:

• Master’s degree and 8 to 10years in Pharmaceutical and/ or Biotechnology Quality, R&D, and/or Manufacturing experience Or
• Bachelor’s degree and 10 to 12 years of in Pharmaceutical and/ or Biotechnology Quality, R&D, and/or Manufacturing experience Or
• Prior technical writing experience in a regulated space

Preferred Qualifications:

• Exceptional attention to detail and accuracy in all deliverables.
• Ability to work independently and proactively in a fast-paced environment.
• Proficiency in Microsoft Office Suite & Collaboration tools.
• Solid understanding of SOP/Standards management, and methods/ technology used to drive knowledge management across a diverse Quality operations environment.
• Complex document management in the Quality with experience in GMP regulations.
• Effective communication, critical thinking and problem-solving
• Experience within Biotech/pharmaceutical Research, including the application of Global Regulations.
• Direct experience working with standard procedural documentation, including their creation, change control (requests for change and the execution of changes.
• Independent and team work capabilities
• Operational and compliance-critical administrative support

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