Quality Stablity Specialist

Open Scientific; Miami (FL); On-site; USD 26,000 - 70,000; Part time

Job summary

Open Scientific is looking for a Stability Specialist to join their dynamic pharmaceutical team in Miami. The position involves preparing stability reports and protocols, entering/trending data, and ensuring compliance with FDA requirements.

Candidates should hold a Bachelor's degree in chemistry or a related field and have a minimum of five years of experience in similar roles. The pay rate is $26 - $28 an hour, with potential permanent salary ranging from $60K to $70K plus great benefits.

Qualifications

• Minimum of Bachelor's degree in chemistry or related field.
• Five or more years of appropriate professional experience.
• Good written English and verbal communication skills.

Responsibilities

• Prepares Stability Reports for FDA Annual Reports.
• Enters or approves LIMs protocols utilizing LabWare LIMs.
• Monitors and performs trending for stability studies.

Skills

Communication skills

Organizational skills

Leadership skills

Knowledge of Stability Program requirements

Knowledge of Microsoft business applications

Education

Bachelor's degree in chemistry or related field

Tools

LabWare LIMS

Statistical software

Job description

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.

Job Description

• 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.
• Monitors 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 assesses 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.
• Assists 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 of 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 is a plus.

Additional Information

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

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