QC Stability Coordinator

Lonza•Tampa, FL
•Onsite

About The Position

The QC Stability Coordinator will manage stability programs in Tampa, Florida, supporting product quality and compliance across development, clinical, and commercial stages. The role coordinates stability studies and their protocols, sample pulls, and storage conditions; monitors and interprets stability data; supports audits; maintains quality records and program databases; and collaborates with cross-functional teams to execute studies and improve processes.

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 and the ability to interpret data and identify trends.
  • Ability to manage multiple priorities and coordinate activities across teams.
  • Effective communication skills with technical and non-technical stakeholders.

Nice To Haves

  • Familiarity with data tools such as Excel and with quality systems.

Responsibilities

  • Coordinate and manage stability studies, including protocols, sample pulls, and storage conditions.
  • Monitor stability data, identify trends, and escalate out-of-specification or out-of-trend results.
  • Prepare documentation and respond to stability-related inquiries in support of audits.
  • Manage stability-program quality records, including deviations, CAPAs, and change controls.
  • Collaborate with Quality Control, Quality Assurance, and Product Development teams on study design and execution.
  • Maintain stability databases, dashboards, and performance metrics to provide program visibility.
  • Drive process improvements to enhance efficiency, compliance, and data reliability.

Benefits

  • Medical, dental, and vision insurance.
  • Career development through cross-functional collaboration and continuous improvement initiatives.
  • Compensation programs that recognize high performance.
  • An agile career and dynamic working culture.
  • An inclusive and ethical workplace.
  • Opportunities to contribute to meaningful work that improves lives.
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