Quality Stablity Specialist

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.