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Stability Program Coordinator GL Staffing Services, Inc. - 3.3 Deerfield Beach, FL Job Details Full-time $60,000 - $65,000 a year 5 hours ago Qualifications Microsoft Word Stability testing Stability studies in drug product development Pharmaceutical regulatory compliance Spreadsheets GMP Data integrity and documentation Schedule management ICH guidelines Bachelor's degree Document management systems FDA regulations Full Job Description We are seeking a detail-oriented Stability Program Coordinator to manage pharmaceutical stability studies in a GMP-regulated environment. This role oversees stability schedules, sample management, chamber monitoring, laboratory testing coordination, and data trending to support product quality, specifications, and beyond-use date (BUD) assignments. Key Responsibilities Maintain the stability master schedule, including study initiation, sample pulls, testing intervals, and study closure. Prepare stability protocols, amendments, summary reports, SOPs, forms, and work instructions for Quality review and approval. Ensure products and batches are enrolled in stability studies according to established procedures. Place samples in qualified chambers under controlled room temperature, refrigerated, and frozen conditions; maintain inventory and reconcile samples against protocols. Perform scheduled sample pulls within required windows and document sample handling and chain of custody. Coordinate contract laboratory shipments, including packaging, temperature control, shipping documentation, and testing. Monitor chamber conditions and alarms, document excursions, and coordinate chamber qualification, calibration, and maintenance with Validation and Facilities. Collect, verify, enter, and trend stability results in electronic databases or LIMS, following ALCOA+ data integrity principles. Identify and escalate out-of-trend (OOT) and out-of-specification (OOS) results and support investigations, deviations, CAPAs, and change controls. Prepare data summaries supporting BUD assignments and extensions, product specifications, quality decisions, and annual product reviews. Support internal audits, regulatory inspections, contract laboratory oversight, and review of laboratory reports and Certificates of Analysis (CoAs). Track program metrics, including on-time sample pulls, testing turnaround, and outstanding items; report status to the Quality Manager. Perform other duties as assigned. Required Qualifications Bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, or a related scientific field. At least 2 years of experience in a GMP-regulated pharmaceutical, 503B, biotechnology, or related laboratory environment, with direct stability program or QC laboratory experience. Working knowledge of 21 CFR Parts 210 and 211, ICH Q1A(R2) stability principles, and data integrity requirements. Proficiency in Microsoft Excel and Word, with experience using LIMS, QMS, or electronic document management systems. Strong organizational, analytical, communication, documentation, and problem-solving skills. Ability to manage multiple studies and deadlines independently, identify quality concerns, and collaborate with QC, Quality, Operations, and external laboratories.