QC Technical Documentation Lead

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

Working independently, the QC Technical Documentation Lead assumes responsibility for creating, editing, reviewing, approving cGMP documents. The Lead’s knowledge of compendia (USP, EP, etc), computerized management systems, Microsoft Suite, and cGMP awareness equips them to support others within QC. The Lead demonstrates familiarity with the authoring, review, revision, and approval process within document management system (DMS). The expectation is to process and format cGMP documents to support timelines.  Lead will use their experience and requirements of the QC Laboratory to create documents that comply with the requirements of the Compendia (United States Pharmacopeia, European Pharmacopoeia and the Japanese Pharmacopoeia). Documents will be revised within quality systems such as VCNs, Change Controls and CAPA. Lead will manage input from QC teams in the review of Qualification Reports, Regulatory Submissions, Product Quality Reports and Annual Product Reviews. May assist other groups in QC with the document changes that are required.

Key Responsibilities:

  • Process cGMP documents: Ensures documents conform to regulatory, industry, compendial and Lonza guidelines
  • Process document change requests with little to no supervision.  Create new documents within the document management system (DMS), display a high comprehension of how DMS functions, and provide assistance to others using the program
  • Lead documentation timelines with Technical Transfer Teams
  • Maintain and manage an organized system of document status via multiple interfaces including but not limited to Excel, DMS, and Outlook
  • Perform data mining in electronic systems and assists in the interpretation of historical data
  • Leads the requalification process and authors reports
  • Perform other duties as assigned

Key Requirements:

  • Significant previous experience editing and/or regulated industry experience
  • Working with teams to meet project timelines and drives assignments to completion
  • Advanced understanding of compendial requirements
  • Technical writing experience (protocols, reports, specifications and methods) as well as proofreading/editing
  • Strong understanding of QC Laboratories
  • Demonstrates ability to learn and use the knowledge to drive improvements
  • Ability to change directions often and work with different internal and external customers to ensure needs are met
  • Advanced level in MS Suite applications, particularly Word and Excel
  • Experience with document management systems (DMS)/document control practices and document change management
  • Coherent and effective interpretation of written and verbal instructions
  • This position will be on site at our Portsmouth NH facility

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law. 

Reference: R37088
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