Quality Stablity Specialist

Our Client is a dynamic specialty pharmaceutical company engaged in the research, development, manufacture, marketing and sale of prescription pharmaceutical products. With a parent company who is the largest manufacturer of pharmaceutical products (in their field) in the world, you will be working in an FDA approved, state-of-the art manufacturing facility in Miami, FL.

This is a contract - to - permanent opportunity (based on performance)  and the pay rate is $26 - $28 an hour. If you are extended a permanent offer the salary could range between $60 to $70K with excellent benefits.

In this role you will be responsible for:

• 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.

• 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 be computer literate with knowledge in all Microsoft business applications. 
• A strong background in software such as LabWare LIMS and statistical software a plus.

Please send suitable resumes in confidence to JPCuadra @ Openscientific.com

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