QA Process Technical Writer Lvl 4

United States, Hayward (California)

Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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.

As an already well-versed technical writer, level 4 writers’ precise and accurate writing, editing, and planning skills bring about a greater leadership role within the External Quality Assurance group and Lonza. These writers become the backbone of the group, providing support within the department and also throughout the business, offering keen insight to process-related knowledge and manufacturing as related to product specifications, CofAs, IPTPs and instructions. Technical Writer Level 4 has a deep understanding of how their work directly affects ease of operations within the building, patient safety, drug quality, and business reputation.

Key Responsibilities:

  • Working independently create process related documents based on technical input from MSAT/ Manufacturing/ External Customer(s)
  • Review and template documents for both upstream and downstream (including buffers and media) with accurate, clear, and explicit description and justifications while developing proficiency in both upstream and downstream processes.
  • Creates new cGMP documents with minimal assistance and supervision.
  • Manage document requirements inputs/comments: Answer and translate questions into the reviewed document to meet regulatory, internal, and external requirements with the aid of document owners
  • Review and maintain document schedules/campaigns: Notify associated departments of deadlines and keep documents within their scheduled timeframe.
  • Work with project team(s) to address post release documentation comments.

Key Requirements:

  • High school diploma or equivalent experience
  • Biotech or pharmaceutical manufacturing industry experience document editing
  • Strong written and oral communication skills
  • Detail oriented
  • Advanced proficiency in MS Suite, particularly Word, Excel, and Project
  • Word Processing experience
  • Able to navigate in Trackwise
  • Highly organized
  • Proofreading/editing

Every day, Lonza’s products and services have a positive impact on millions of people. For us, this not only a great privilege, but also a great responsibility.  How we achieve our business results is just as important as the achievement 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: R30375
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