Quality Record Coordinator Level IV at US03 Lonza Walkersville Inc. in Walkersville, Maryland

Job Description:

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 Walkersville  has a great opportunity for a Quality Record Coordinator Level IV. This role is responsible for the initiation, investigation and completion of quality records (deviations, CAPAs, Out of Specifications, etc.) aimed at identification of root cause, and implementation of correct actions to prevent recurrence. The Quality Record Coordinator is expected to work in a cGMP environment, have an expert level working knowledge of manufacturing processes, the ability to manage multiple ongoing projects concurrently as well as mentor and train others within the group, have excellent meeting facilitation and conflict resolution skills, a professional and expert technical writing capability, be action oriented, and be compliant minded while performing investigations.

Key responsibilities:

• Technical writing for the educated but uninformed reader, translating difficult and complex scientific events into a brief and cohesive report as a finished product.  Addressing comments from both internal and external clients on the compiled filed report


• Gathering data from various sources across the site, lead and perform Root Cause Analysis (RCA) to determine the most likely cause of the deviation, Assessment of event for impact to SISQP, Identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Cause Mapping, 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 on 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


• Meeting facilitation and participation, aligning internal 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


• Mentoring and training of Deviation Investigator / Initiators. 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.


• Perform other duties as assigned.

Key requirements:

• High school diploma required; Bachelors degree in a Scientific discipline preferred


• 5 year minimum experience working in a manufacturing environment or troubleshooting manufacturing related issues and Technical Writing experience required

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.