Stability Coordinator

MissionHires is seeking a detail-oriented Stability Coordinator on behalf of a pharmaceutical company committed to improving access to affordable medicines. This Quality Control role is responsible for coordinating and overseeing product stability testing programs in an FDA-regulated cGMP environment, including protocol development, study initiation, sample management, data trending, reporting, and compliance support.
How You'll ContributeDraft, review, and maintain stability study protocols in accordance with ICH guidelines, FDA regulations, and internal SOPs.Initiate stability studies for manufactured batches, registration lots, validation studies, and annual commercial monitoring.Coordinate stability sample laydown in designated chambers under required storage conditions, including standard, accelerated, and stress conditions.Manage scheduled stability timepoint pulls within protocol-defined windows and assign samples to internal laboratories or external testing vendors.Maintain organized stability chambers, chamber maps, environmental monitoring records, and associated logbooks.Collect, verify, compile, and track laboratory testing results from internal and external laboratories across all stability timepoints.Prepare interim and final stability reports supporting shelf-life determinations, regulatory filings, annual product reviews, and regulatory submissions.Perform statistical trending and analysis of stability data to identify out-of-trend results, degradation patterns, and shelf-life projections.Use LIMS, Smartsheet, Excel, or similar systems to manage sample tracking, schedules, timepoints, and data entry.Support investigations related to OOS and OOT results, chamber excursions, deviations, and stability sample issues.Participate in CAPA activities, root cause analysis, and continuous improvement initiatives for the stability program.Serve as a stability program subject matter expert during internal audits and regulatory inspections.Coordinate shipments to third-party testing laboratories, maintain chain-of-custody documentation, and ensure complete and timely data return.Collaborate effectively with Quality Control, Quality Assurance, manufacturing, regulatory, and external laboratory partners.
What Makes You a Great FitBachelor’s degree in Chemistry, Biology, Life Sciences, or a related scientific or technical discipline.2–4 years of relevant Quality Control or stability laboratory experience in an FDA-regulated cGMP environment.Hands-on experience executing stability programs, including protocol drafting, study initiation, sample laydown, and timepoint pulls.Working knowledge of ICH stability guidelines, including Q1A through Q1E, cGMP requirements, FDA regulations, and pharmaceutical documentation practices.Experience trending stability data, conducting statistical evaluations, and preparing formal stability reports.Strong attention to detail, organization, documentation, and record-keeping skills.Clear written and verbal communication skills, including the ability to prepare technical reports and coordinate with internal and external stakeholders.Ability to support investigations involving OOS, OOT, deviations, and stability chamber excursions.Experience using LIMS, Smartsheet, Excel, or comparable data-management and sample-tracking systems.Preferred: Experience drafting SOPs and product specifications.Preferred: Experience coordinating external testing vendors and third-party sample shipments.