Quality Stability Specialist

Open Scientific; Miami (FL); On-site; USD 85,000 - 120,000; Full time

Job summary

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

Qualifications

• 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.

Responsibilities

• 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.

Skills

Stability knowledge

Leadership

Communication skills

Microsoft Office

Organizational skills

English proficiency

Education

Bachelor's degree in Chemistry

Tools

LabWare LIMS

Statistical software

Microsoft Excel/Office

Job description

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

Job Description

This job is located in South Miami

Responsibilities

• Prepares Stability Reports for FDA Annual Reports and Annual Product Reviews.
• Prepares Stability Protocols for Annual and Special Studies.
• Enters or approves LIMs protocols utilizing LabWare LIMs.
• Monitor and performs trending for stability studies using statistical tools as appropriate.
• Prepares Change Controls and Investigations as required in support of the Stability Program.
• Participates in Change Control Review Board and assess changes impacting product stability
• Performs annual lot tracking and coordinates with appropriate departments the selection of stability samples.
• Reviews and approves stability data based on product trending.
• Assist the Stability Technician in sample pulling as required.

Qualifications

• Minimum of Bachelor's degree in chemistry or related field.
• Five or more years of appropriate professional experience preferably in a similar position (Stability Specialist) or in the QA/Technical Services and/or Manufacturing areas.
• Knowledge on Stability Program requirements. .
• Good written English and verbal communication skills.
• Must be highly organized and able to work under pressure.
• Must have strong interpersonal and leadership skills.
• Must have computer literate with knowledge in all Microsoft business applications.
• A strong background in software such as LabWare LIMS and statistical software a plus.

Additional Information

All your information will be kept confidential according to EEO guidelines.