Viral Vector - Deviation Investigation Writer

United States, Houston (Texas)

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.

Lonza Cell and Gene Therapy Facility is the largest in the world and our facility is growing. We are looking for professionals to grow with us and we have this exciting opportunity the Viral Vector Therapy group https://www.lonza.com/viraltherapy  The Deviation Investigator - Senior will be responsible for the initiation, investigation of any Minor, Major, or Critical process deviations aimed at identification of root cause, determining Product Quality impact (PQI) and implementation of correct actions to prevent recurrence.

Key responsibilities:

  • Technical writing for the educated but uninformed reader, translating very complex and challenging scientific events into a brief and cohesive report as a finished product.  Accurately capture immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report.
  • Gathering Data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation, assessment of event for impact to SISQP, perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Cause Mapping, and Interviewing.
  • Management of multiple projects and timelines concurrently. Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner. Participation in the Daily Management meetings to update leadership or current deviation statuses.
  • Routine interaction with the customer, including compilation of Power Points to communicate investigational current status, Alignment meetings, facilitated reviews, CAPA discussions, Comments resolution.
  • Work on the manufacturing floor for data gathering, observing of processes for investigations, and performance of associate interviews.
  • Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward. Complex Conflict resolution, problem solving in a cross functional setting, and ability to keep the meeting on track to achieve objectives of varying difficulty, inclusive of complex technical topics. Attendance and leadership of the daily management system, and leading the deviation review board.
  • Mentoring and training of Deviation Investigator / Initiators Levels 1, 2, and 3. Provide investigation guidance and expertise for complex deviation investigations to the team, as well as to associated cross functional teams in order to drive to root cause of the events.

Key requirements:

  • Bachelor’s Degree in field of science or diploma with relevant experience
  • Advanced experience in Technical investigating
  • Background in Biopharmaceutical
  • Familiarity with cGMP quality systems.
  • Ability to read and comprehend GMP documents (i.e. SOPs, logs, and Batch Records).
  • Exposure to Manufacturing – 1-2 years preferable

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: R31415
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