Quality Control, Senior Lead Analyst - Environment Monitoring (Biotech)
Today, Lonza is a global leader in life sciences operating across five 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 you to be part of.
Act as a team member of the Quality Control department to lead external or internal projects based on their area of focus. Considered a subject matter expert for one or more areas. Technical writer of QC documentation including test methods, protocols, reports, SOP's, change controls and deviations. Acts independently to determine methods and procedures on new assignments and may provide guidance and oversee the activities of other QC personnel. Works on complex problems in which analysis of situations or data requires an evaluation of intangible variables. Acts as advisor to unit or sub-units becomes actively involved as required to meet schedules or resolve problems. Provides general or direct supervision to employees.
Key Responsibilities:
Accurately captures immediate actions and containment of events, addresses comments from both internal and external (when applicable) clients. Technical writing for the educated but uninformed reader (EM excursion investigations, EM deviations, EM trending, CAPA, change controls).
Gather data from various sources across the site in support of Root Cause Analysis (RCA) for environmental monitoring excursion investigations and deviations. Perform trending analysis, identification of Corrective and Preventative Actions (CAPA) to reduce recurrence.
Perform project management for area of focus. Independently drive projects to on-time completion.
Technical writer of QC documentation including test methods, protocols, reports, SOPs, change controls and deviations.
Attending meetings and representing the department to both internal and external customers.
Provide guidance to junior staff or other departments to achieve goals in accordance with established
policies.
Other – such as leading OE initiatives, Improvements.
Manage multiple projects and timelines concurrently with on time completion and closure. Supporting Sterility Assurance (SA), Validation, Manufacturing with EM deliverables.
Understand regulatory requirements and Lonza policies/procedures as they apply to EM.
Back-up to Supervisor – independently making quality decisions with input.
Review/approve assays.
Train others.
Projects such as method transfers, new instruments, method qualifications.
Perform other duties as assigned.
Key Requirements:
Bachelor's degree and/or relevant experience.
Preferred area of study: Microbiology, Biochemistry or equivalent Science Field.
Preferred 10+ years in a GMP/Professional environment.
Strong organizational and time management skills. Ability to manage multiple priorities.
Strong knowledge of QC procedures, processes and methods. Is recognized by colleagues as a source of expertise.
Able to interpret data. Prioritization and problem solving.
Perform assigned, complex and/or varied tasks. Direct, control and plan tasks/projects.
Demonstrates speed and flexibility to adapt to changes.
Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects/schedules, etc.
Exercises independent judgment in execution, transfer or investigation of methods, techniques and evaluation criteria for obtaining results, performing laboratory activities and/or taking appropriate actions.
Self-motivated team player. Maintain positive attitude and emotional composure in a team
environment. Relate to others in a team setting. Communicates well with all members of the team.
Able to coordinate and drive training in new hires.
Timeliness in completing assigned tasks.
Displays a high level of awareness to internal business drivers (cost, quality, quantity, safety, etc.)
Use of Microsoft Suites (Word, Excel, Powerpoint).
Use of Laboratory computer systems.
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS, iLAB.
Strong written and oral communication skills including public speaking. Able to clearly express ideas and point of view both verbally and in writing.
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.
