Quality Control Records Investigator

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. The Quality Control Records Investigator is responsible for tracking, management, and completion of QC Quality Records (such as deviations, lab investigations, change control, and CAPA) in partnership with applicable SMEs. Leads error prevention and continuous improvement initiatives based on identified recurring root cause. Key responsibilities: Serves as the Quality Record (PR) Subject Matter Expert (SME) for the Quality Control team and provides mentorship and training to Record Investigators Responsible for initiation, investigation and completion of Minor, Major and Critical process deviations aimed at identification of root cause, and implementation of corrective actions to prevent recurrence Provides 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 captures immediate actions and containment of the event, address comments from both internal and external clients on the compiled final report Displays ability to gather data from various sources across the site, performance of Root Cause Analysis (RCA) to determine the most likely cause of the deviation investigation Demonstrates proper assessment of event for impact to Safety Identity Strength Quality Purity (SISQP), perform trending analysis, identification of Corrective and Preventative Actions to reduce deviation recurrence, performance of Risk Assessments, Causing Mapping, Interviewing 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 Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward 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 Ensures escalations are accurately identified and communication to leadership Generously shares information and knowledge with others across the team Provides 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 Treats all co-workers and customers professionally and with respect Attendance and leadership of the daily management system, and active participation at the deviation review board Performs other duties as assigned Key requirements: Bachelor Science degree required Experienced knowledge working in Quality Control Prior experience working in a laboratory setting required Prior experience with TrackWise preferred. Proficient in the use of spreadsheets, databases, and word processing software (MS Word & Excel and/or Visio) In-depth knowledge of cGMP principles and able to identify breach of cGMP principles and provide suggested corrective actions Problem solving in a cross-functional setting, and participation and attendance at the deviation review board Able to propose ideas during problem solving, root cause analysis, and process improvement events. Provides suggestions for improvement to documentation and workflows. 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 Assist with meeting facilitation and participation, capable of aligning internal review team and area subject matter experts on an agreed-to investigational path forward Meeting Facilitation and participation, aligning internal review team and area subject matter experts on an agreed to investigational path forward Communicates verbally and in writing in a clear and concise manner. Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding. Capable of effectively representing the department in meetings and on project teams. Provides timely, clear, and accurate updates without being prompted. Participation in the Daily Management meetings to update leadership or current deviation statuses Ability to adhere to standard timeline, and escalate actions appropriately for resolution in a timely manner Dependable and able to work well within a team. Capable of effectively representing the department in meetings and on project teams. Provides 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 Actively attempts to understand the logic or basis for change in tasks or situations. Able to identify trends in testing. Is considered a go-to person for assistance. Work on the lab floor for data gathering and observing of processes for investigations Willing to pursue opportunities that can lead to substantial benefit, even if there are risks involved 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.