Stability Coordinator - Dallas, TX

MissionHires; Dallas (TX); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Mission-driven organization

Cross-functional collaboration

Professional development

Job summary

MissionHires is seeking a Stability Program Analyst to draft and maintain stability protocols, initiate studies, and coordinate sample laydown across standard, accelerated, and stress conditions.

You will manage timepoint pulls, track data in LIMS/Smartsheet/Excel, and prepare interim/final reports for regulatory submissions, while supporting investigations and CAPA activities.

Qualifications

• Bachelor’s degree in Chemistry, Biology, Life Sciences, or related discipline.
• 2–4 years of QC or stability lab experience in FDA-regulated cGMP settings.
• Experience drafting and executing stability protocols and initiating studies.
• Solid knowledge of ICH guidelines (Q1A–Q1E), cGMP, FDA documentation practices.

Responsibilities

• Draft, review, and maintain stability study protocols per ICH, FDA, and SOPs.
• Initiate stability studies for batches, registration lots, validation, and annual monitoring.
• Coordinate stability sample laydown under standard, accelerated, and stress conditions.
• Manage timepoint pulls and assign samples to internal labs or external vendors.
• Maintain stability chambers, chamber maps, EM records, and logbooks.
• Collect, verify, and track lab results across stability timepoints.
• Prepare interim and final stability reports for shelf-life, regulatory filings, and reviews.
• Perform statistical trending to identify degradation patterns and shelf-life projections.
• Use LIMS, Smartsheet, Excel for data entry and sample tracking.
• Support investigations related to OOS/OOT, deviations, and chamber excursions.
• Participate in CAPA and continuous improvement; act as SME during audits.
• Coordinate shipments to third-party labs and ensure data return.
• Collaborate with QC, QA, manufacturing, regulatory, and external labs.

Skills

Attention to detail

Documentation

Communication

Team collaboration

Education

Bachelor’s degree in Chemistry, Biology, Life Sciences, or related

Tools

LIMS

Smartsheet

Excel

Job description

Responsibilities:

• Draft, 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.

Requirements:

• Bachelor’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.

Benefits:

• Opportunity to contribute to a mission-driven organization focused on making essential medications more accessible and affordable.
• Meaningful work supporting product quality, regulatory compliance, and patient access to medicine.
• Collaborative environment grounded in transparency, affordability, integrity, resilience, professionalism, empathy, and employee advocacy.
• Opportunity to build expertise in pharmaceutical stability programs, quality systems, and regulatory readiness.