Quality Stability Specialist

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.