Stability Coordinator

Job Details

Level

Experienced

Job Location

Pegasus - Pensacola, FL

Pegasus Laboratories, Inc.

Pegasus Laboratories, Inc. is a full-service Contract Development and Manufacturing Organization, or CDMO, with a very special purpose: improving the lives of animals. Through our leading veterinary brand, PRN Pharmacal, we create trusted veterinary products that promote animal wellness, including behavior modification, urinary incontinence, and seizure management. Our team of professionals, including manufacturing, quality assurance, business development, scientists and chemists, regulatory experts, and veterinarians, offers the complete package, from idea through development and regulatory approval, to production and marketing.

Pegasus Labs, part of the PBI-Gordon Companies, Inc., is 100% employee-owned with more than 500 employee-owners, working together in pursuit of mutual success. We are growing - come join us!

The Stability Coordinator oversees the stability system that complies with current GMPs and corporate standards. The Stability system at Pegasus Laboratories is compose of the following components: Stability chambers and parts, data loggers and Digi ports, ViewLinc software and network, ScienTek Stability System software, stability documentation including protocols, test sheets, reports (Notifications, annual stability reports including statistical and graphical analyses, interim reports, final reports) and laboratory investigations regarding stability samples.

• Author stability protocols according to ICH, FDA and/or WHO guidelines for finished pharmaceutical products.
• Ensure stability protocols are executed and strictly adhered to.
• Ensure the proper sampling and submission of all finished pharmaceuticals requiring stability study initiation.
• Monitor and submit stability samples for analysis on an ongoing day to day basis according to SOP policy.
• Provide statistical treatment, if applicable, for stability studies to ensure shelf life expectations for both commercial products and development products and communicate results to internal and external clients as needed.
• Provide timely stability reports for product review.
• Maintain inventory-tracking system for all stability samples.
• Take a lead role in managing and directing laboratory investigations regarding stability samples where laboratory error is not suspected.
• Monitor all conditions within each stability chamber to ensure proper storage conditions are maintained.
• Create temperature and/ or Temperature and humidity monitoring reports on a monthly basis.
• Perform Annual mapping (calibration) for all stability chambers.
• Ensure proper maintenance procedures are performed for each stability chamber.
• Daily interaction with multiple software suites: Stability System 2008, ViewLinc and vLog.
• Take a lead role in updating stability chamber and stability software qualifications as needed when changes are implemented.
• Ensure data loggers are sent for calibration when due and replaced when needed.
• Ensure stability folders are created, maintained with all required documentation and close out when the study is completed.
• Monitor chart recorders as assigned by the QC Supervisor.

Qualifications:

• Education: BS or BA in Chemistry or related science field.
• Experience: 2+ years in GMP laboratory.
• Specialized knowledge: GMP Requirements for Pharmaceutical Laboratories, ICH Guidelines.
• Knowledge of Stability Tracking Software and Environmental monitoring software is a plus.
• Laboratory testing experience desirable.
• Special skills:
• Excel and Microsoft Word
• Experience in cGMP documentation and regulatory guidance
• Attention to detail
• Able to communicate and listen effectively
• Effective verbal and written communication skills
• Ability to follow written procedures and document all activities in an accurate manner
• Ability to work effectively in a team environment