Stability & QA Specialist — FDA Reports & LabWare LIMS

Open Scientific; Miami (FL); Presencial; USD 85 000 - 120 000; Tempo integral

Resumo da oferta

Open Scientific is seeking a Stability Specialist for our South Miami location. The role focuses on maintaining stability programs, generating FDA-ready reports, and coordinating annual reviews.

You will prepare protocols, manage LIMs entries, and trend stability data using statistics while supporting change controls and investigations. The ideal candidate has a Bachelor’s degree in chemistry and 5+ years in stability or QA/Manufacturing roles, with strong English communication and leadership

Qualificações

• Bachelor's degree in chemistry or related field required.
• Five+ years of professional experience in stability, QA/technical services or manufacturing roles preferred.
• Knowledge of stability program requirements and regulatory expectations.

Responsabilidades

• Prepares Stability Reports for FDA Annual Reports and Annual Product Reviews.
• Prepares Stability Protocols for Annual and Special Studies.
• Enter or approve LIMs protocols using LabWare LIMS.
• Monitor and perform trending for stability studies using statistical tools.
• Prepare Change Controls and Investigations in support of the Stability Program.
• Participate in Change Control Review Board and assess changes impacting product stability.
• Coordinate stability sample selection with appropriate departments and perform annual lot tracking.
• Review and approve stability data based on product trending.
• Assist Stability Technician with sample pulling as required.

Conhecimentos

Stability knowledge

Leadership

Communication skills

Microsoft Office

Organizational skills

English proficiency

Formação académica

Bachelor's degree in Chemistry

Ferramentas

LabWare LIMS

Statistical software

Microsoft Excel/Office

Descrição da oferta de emprego

Open Scientific is seeking a Stability Specialist for our South Miami location. The role focuses on maintaining stability programs, generating FDA-ready reports, and coordinating annual reviews.

You will prepare protocols, manage LIMs entries, and trend stability data using statistics while supporting change controls and investigations. The ideal candidate has a Bachelor’s degree in chemistry and 5+ years in stability or QA/Manufacturing roles, with strong English communication and leadership