Stability Coordinator/Associate QC Chemist in Seminole, Florida at Eagle Labs, Inc

Overview:

The Stability Coordinator/Associate Chemist is responsible for the administration of the stability program which includes, scheduling of the stability sample pull points, pulling samples, scheduling and sending out samples for testing, monitoring environmental stability storage chambers and setting the samples down on stability according to the relevant procedures, supporting the site's Stability Program coordinating sample management activities, and ensuring compliance with cGMP, SOPs, and ICH guidelines.

Additional responsibilities are to perform testing, review, approve data, ensure cGMP/GLP practices are following regulatory requirements, equipment management/maintenance, lead investigations, deviations, out-of-specifications (OOS). Collaborate with Quality control manager, director and other departments.

Requirements:

• Applicant must have a bachelor's degree with at least 3-5 years of experience
• Stability program experience required
• Relevant Quality experience, preferably in the bio/pharmaceutical/supplemental and/or nutraceutical industry
• Knowledge of stability and cGMPs
• An understanding of stability testing, FDA, ICH, and applicable stability regulations is required
• Knowledge in statistical concepts for appropriate interpretation of stability data (e.g. trending analysis)
• Strong technical writing skills
• Proficiency with computer systems (Microsoft Office applications)
• Experience with document management systems
• Strong interpersonal and communication (written and oral) skills and the ability to work well in a team environment are essential)
• Normal lifting, sitting, standing and walking requirements to facilitate support of staff in the office

Responsibilities:

• Conducting and overseeing stability studies to ensure product quality and compliance with regulatory guidelines
• Providing support for product testing and analysis, including sample preparation, data analysis, and report writing
• Maintaining and updating quality control documentation and record
• Identifying and resolving quality control issues and deviations in a timely manner
• Collaborating with cross-functional teams to ensure timely completion of projects and adherence to quality standards
• Communicating with external vendors and suppliers to ensure timely delivery and quality of materials and with outside contract laboratories on testing.

• Enter studies into the computerized stability management system in accordance with SOPs.
• Compile, interpret, and evaluate data and identify impacts related to deviations, OOS/OOT results, or excursions.
• Maintain inventory, coordinate final sample destruction, and reconcile stability materials.
• Prepare samples for shipment, complete related documentation, and perform peer reviews.
• Ensure compliance with cGMP, quality policies, and guidelines.
• Review internally and externally produced laboratory data for finished products and raw materials.
• All other duties as assigned.

Education:

• Bachelor’s degree in related scientific discipline and 4-5 years of experience with documentation systems and cGMP-compliant environments required.
• Experience with sample tracking is preferred.
• Strong organizational, technical writing, and communication skills.
• Knowledge of stability program expectations, sample handling, data integrity, and QMS principles.
• Proficiency with Microsoft Outlook, Excel, and Word.