QC Stability Coordinator
Lonza
Summary
As a QC Stability Coordinator in Tampa, you will play a critical role in managing stability programs that ensure product quality and compliance across development, clinical, and commercial stages.
Job description
What you will do
- You will coordinate and manage stability studies, including protocols, sample pulls, and storage conditions.
- You will monitor stability data, identify trends, and escalate out-of-specification or out-of-trend results.
- You will support audits by preparing documentation and responding to stability-related inquiries.
- You will manage quality records such as deviations, CAPAs, and change controls within the stability program.
- You will collaborate with Quality Control, Quality Assurance, and Product Development teams to support study design and execution.
- You will maintain stability databases, dashboards, and performance metrics to ensure program visibility.
- You will drive process improvements to enhance efficiency, compliance, and data reliability.
What we are looking for
- Associate degree or higher in a scientific or related discipline.
- Experience in a regulated environment such as pharmaceutical, biotech, or laboratory settings.
- Knowledge of GMP and stability program requirements, including regulatory guidelines.
- Strong analytical skills with the ability to interpret data and identify trends.
- Ability to manage multiple priorities and coordinate activities across teams.
- Effective communication skills with both technical and non-technical stakeholders.
- Familiarity with data tools (e.g., Excel) and quality systems is preferred.
Requirements
- Associate degree or higher in a scientific or related discipline.
- Experience in a regulated environment such as pharmaceutical, biotech, or laboratory settings.
- Knowledge of GMP and stability program requirements, including regulatory guidelines.
- Strong analytical skills with the ability to interpret data and identify trends.
- Ability to manage multiple priorities and coordinate activities across teams.
- Effective communication skills with both technical and non-technical stakeholders.
- Familiarity with data tools (e.g., Excel) and quality systems is preferred.
Benefits
- Medical, Dental & Vision
- Career Development
- Inclusive Workplace
- Agile Career Culture
- Compensation Programs
Company overview
Lonza is a pioneering global Contract Development and Manufacturing Organization (CDMO) and a world leader in pharmaceutical manufacturing services. Founded in 1897 in Switzerland, the company has evolved into the first and original CDMO, now operating as one of the largest Western CDMO networks with approximately 19,000 employees across more than 30 sites spanning five continents. Lonza specializes in transforming therapeutic discoveries into life-saving and life-enhancing treatments for patients worldwide. The company's comprehensive services span from early development to drug substance and drug product manufacturing, covering established and emerging technologies including mammalian biologics, small molecules, highly potent APIs, bioconjugates, mRNA, microbial products, and cell and gene therapies. With a focus on cutting-edge science, smart technology, and lean manufacturing, Lonza serves a diverse customer base ranging from emerging biotechs to global pharmaceutical companies, delivering integrated solutions throughout the entire treatment lifecycle.