Lonza, Inc.
Supply Chain - Deviation investigator Writer
Lonza, Inc., Houston, Texas, United States, 77020
Deviation Investigator Writer
Houston, TX
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 Houston's 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 in Cell Therapy.
The Deviation Investigator Writer identifies and investigates process deviations to find the cause, assess product quality impact, and implement corrective actions. They also represent the company in audits, client meetings, and management meetings.
Key responsibilities:
* Translating complex and challenging scientific events into a concise report for the educated but uninformed reader, showcasing outstanding clarity and coherence. Authoritatively consolidating immediate actions and containment measures while incorporating feedback from internal and external clients into the final report.
* Collecting data from different sources, analyzing causes of deviations, evaluating impact, identifying actions to prevent recurrence, and conducting risk assessments and interviews.
* Advancing multiple projects and timelines simultaneously. Following strict timelines and bringing up issues appropriately to resolve them promptly. Participating in Daily Management meetings to update leadership on current deviations.
* Routine interaction with the customer, including the compilation of PowerPoint's to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and comments resolution.
* Working on the manufacturing floor for data gathering, observing processes for investigations, and performing associate interviews.
* Facilitating and participating in meetings, aligning the internal review team and area subject matter experts on an agreed investigational path forward. Engaging in complex conflict resolution, problem-solving in a cross-functional setting, and keeping the meeting on track to achieve objectives of varying difficulty, inclusive of sophisticated technical topics. Leading the daily management system and the deviation review board.
* Mentoring and training team members. Offering mentorship and expertise for intricate deviation investigations to the team, as well as to cross-functional teams, in order to identify the underlying cause of events.
* Performing other duties as assigned.
Key requirements:
* Bachelor of Arts/Science or equivalent combination of education minimum.
* Preferred field of study: Biochemistry, Chemical Engineering, Biology, or another relevant science field.
* Prior experience in technical writing; experience in a biotech/life science manufacturing environment preferred.
* Familiarity with cGMP quality systems.
* Experience working with Trackwise software.
* Ability to work in a fast-paced, high workload environment, and balance multiple projects and objectives for timely event closure.
* Collaboration skills, with the ability to troubleshoot and problem solve in a cross-functional team setting.
* Ability to work independently, be committed, productive, willing to take action, and adapt to change.
* Ability to identify and flag risks in a timely manner to keep deliverables on track.
* Proven logic and decision-making abilities, critical thinking skills.
* Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint).
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.
Houston, TX
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 Houston's 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 in Cell Therapy.
The Deviation Investigator Writer identifies and investigates process deviations to find the cause, assess product quality impact, and implement corrective actions. They also represent the company in audits, client meetings, and management meetings.
Key responsibilities:
* Translating complex and challenging scientific events into a concise report for the educated but uninformed reader, showcasing outstanding clarity and coherence. Authoritatively consolidating immediate actions and containment measures while incorporating feedback from internal and external clients into the final report.
* Collecting data from different sources, analyzing causes of deviations, evaluating impact, identifying actions to prevent recurrence, and conducting risk assessments and interviews.
* Advancing multiple projects and timelines simultaneously. Following strict timelines and bringing up issues appropriately to resolve them promptly. Participating in Daily Management meetings to update leadership on current deviations.
* Routine interaction with the customer, including the compilation of PowerPoint's to communicate investigational current status, alignment meetings, facilitated reviews, CAPA discussions, and comments resolution.
* Working on the manufacturing floor for data gathering, observing processes for investigations, and performing associate interviews.
* Facilitating and participating in meetings, aligning the internal review team and area subject matter experts on an agreed investigational path forward. Engaging in complex conflict resolution, problem-solving in a cross-functional setting, and keeping the meeting on track to achieve objectives of varying difficulty, inclusive of sophisticated technical topics. Leading the daily management system and the deviation review board.
* Mentoring and training team members. Offering mentorship and expertise for intricate deviation investigations to the team, as well as to cross-functional teams, in order to identify the underlying cause of events.
* Performing other duties as assigned.
Key requirements:
* Bachelor of Arts/Science or equivalent combination of education minimum.
* Preferred field of study: Biochemistry, Chemical Engineering, Biology, or another relevant science field.
* Prior experience in technical writing; experience in a biotech/life science manufacturing environment preferred.
* Familiarity with cGMP quality systems.
* Experience working with Trackwise software.
* Ability to work in a fast-paced, high workload environment, and balance multiple projects and objectives for timely event closure.
* Collaboration skills, with the ability to troubleshoot and problem solve in a cross-functional team setting.
* Ability to work independently, be committed, productive, willing to take action, and adapt to change.
* Ability to identify and flag risks in a timely manner to keep deliverables on track.
* Proven logic and decision-making abilities, critical thinking skills.
* Strong written and verbal communication skills are required. Ability to read and comprehend complex subjects. Strong typing and computer skills, including efficiency using Microsoft Office Suite (Word, Excel, PowerPoint).
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.