Stability Coordinator

Mark Cuban Cost Plus Drug Company, PBC; United States; On-site; USD 70,000 - 95,000; Full time

Job summary

Mark Cuban Cost Plus Drug Company, PBC is seeking a detail-oriented Stability Coordinator to oversee product stability testing programs in a cGMP environment. You will draft protocols, initiate studies, manage sample laydowns, and analyze stability data to support shelf-life determinations and regulatory filings.

The role requires 2–4 years in QA or stability labs, knowledge of ICH guidelines, and experience with LIMS/Smartsheet/Excel.

Qualifications

• 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 (Q1A–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 for technical reports and coordination with 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.

Responsibilities

• Draft, review, and maintain stability study protocols per ICH guidelines, FDA regulations, and SOPs.
• Initiate stability studies for batches, registration lots, validation studies, and annual monitoring.
• Coordinate stability sample laydown in chambers under storage conditions (standard, accelerated, stress).
• Manage stability timepoint pulls within protocol-defined windows and assign samples to labs or vendors.
• Maintain stability chambers, maps, environmental records, and logbooks.
• Collect, verify, and track testing results from internal/external labs across all timepoints.
• Prepare interim and final stability reports for shelf-life determinations and regulatory filings.
• Perform statistical trending and analysis to identify out-of-trend results and shelf-life projections.
• Use LIMS, Smartsheet, Excel for sample tracking and data entry.
• Support investigations related to OOS/OOT, excursions, deviations, and stability issues.
• Participate in CAPA, root cause analysis, and continuous improvement of the stability program.
• Serve as SME during internal audits and regulatory inspections.
• Coordinate shipments to third-party labs and ensure data return with chain-of-custody.

Skills

Attention to detail

Organizational skills

Technical documentation

Communication skills

Problem-solving

Team collaboration

Auditing readiness

Education

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

Tools

LIMS

Smartsheet

Excel

Job description

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 Contribute

• 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.

What Makes You a Great Fit

• 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.