Quality Control Stability Coordinator
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 (QC) Stability Coordinator is responsible for the generation of stability protocols, entry of stability studies into tracking software, distributing the stability schedule, submission of stability samples, statistical trending of results, compilation of the interim time point reports, and generation of final study reports. The stability coordinator will maintain stability inventories, assess stability equipment/material/personnel needs, and trend equipment parameters. The stability coordinator will attend internal and client meetings to provide stability status updates regarding, but not limited to: time point testing, protocol revision/development status, or investigations into aberrant results.
- Development, generation, and revision of stability study protocols according to customer, regulatory, departmental and internal corporate requirements and timelines.
- Preparation and distribution of the stability schedules and communicating and collaborating with Quality Control supervisors and analysts, Quality Assurance, Project Management, and Process Development personnel, and clients concerning stability workload and schedules to ensure timelines are met.
- Preparation of sample shipments and submission paperwork for contract laboratory testing. Review of data received from contract lab for current Good Manufacturing Practice compliance.
- Maintain and improve management tools for stability studies, as required.
- Provide support to other functions with the Quality Control Support Services team such as assistance with LIMS software administration, sample receipt and coordination activities, and Quality Records Investigation
- Bachelor of Science in a related field and advanced level of relevant experience.
- Experience in the biotech/pharmaceutical industry.
- Advanced skills in spreadsheet creation, record keeping, and planning.
- Demonstrated success with written and verbal communication along with good problem solving skills, and ability to work in a fast-paced environment.
- In-depth knowledge of current Good Manufacturing Practice principles. Able to identify breach of current Good Manufacturing Practice principles and provide suggested corrective actions.
- Is developing Subject Matter Expertise and is recognized as a source of reliable information.
- Prior experience with SAP and TrackWise a plus.
- Extended knowledge of stability study environment chambers/equipment a plus.
- Uses knowledge of defined Standard Operating Procedures & policies to make decisions. Reviews more complex decisions with supervisor and/or other departments.
- Records test results and maintains raw data and accurate laboratory records.
- Is able to effectively present information and ideas formally and informally to others in a manner that facilitates understanding.
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.